Endoscopy - Boston Scientific
Endoscopy - Boston Scientific
Endoscopy - Boston Scientific
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Medicare Category Codes (C-codes)<br />
C-Code Cross Reference Guide and Summary<br />
Updated: January 2011<br />
See important notes on the uses and limitations of this information on page 22.<br />
<strong>Endoscopy</strong><br />
Medicare Hospital Outpatient Ambulatory Payment Classification<br />
(APC) Pass -Through List C-code Cross-Reference Guide to <strong>Boston</strong> <strong>Scientific</strong> Products<br />
Medicare Reinstates C-codes Effective January 1, 2004<br />
Effective January 1, 2004, Medicare reinstated the 95 pass-through codes that were retired on<br />
1/1/03. These C-codes, which only apply to Medicare hospital outpatient claims, will not trigger<br />
additional payment to the outpatient hospital facility. They have been reinstated to assist<br />
Medicare in establishing future APC rates.<br />
Below is an excerpt from the Centers for Medicare and Medicaid Services (CMS) — the<br />
federal agency that oversees the Medicare program — November 7, 2003 Outpatient<br />
Prospective Payment System (OPPS) Final Rule: “For 2004, we (CMS) are reactivating the C<br />
codes for device categories as they existed on December 31, 2002.” As of January 1, 2005,<br />
the Centers for Medicare and Medicaid Services (CMS) requires hospitals to report all device<br />
category codes (C-codes) on Medicare outpatient claims when medical devices are used in<br />
conjunction with procedure(s) billed. If C-codes are not identified on submitted Medicare<br />
outpatient claims, the claims(s) will be returned to the hospital for correction.<br />
Background<br />
APC refers to the hospital outpatient payment system that was made effective on August 1,<br />
2000. This system, mandated by federal law to replace the former retrospective cost-based<br />
reimbursement system, utilizes pre-set, capped payments for each APC. APCs cluster<br />
outpatient procedures into groups based on comparable resource use and clinical similarities.<br />
APCs pertain to Medicare outpatient services only and have no bearing on Medicare inpatient<br />
or physician reimbursement.<br />
Final PSST# MVG16780<br />
Page 1 of 24
C-Code Summary<br />
C-code C-code Description Devices Impacted 1<br />
C1726 Catheter, balloon dilation, non-vascular CRE Single-Use Fixed Wire Balloon Dilators<br />
CRE Single-Use Pulmonary Balloon Dilators<br />
CRE Single-Use Wire-Guided Esophageal/Pyloric<br />
Balloon Dilators<br />
CRE Single-Use Wire-Guided<br />
Esophageal/Pyloric/Colonic Balloon Dilators<br />
Hurricane® RX Single-Use Biliary Balloon Dilatation<br />
Catheters<br />
MaxForce Single-Use Biliary Dilatation Balloon<br />
MaxForce Single-Use Esophageal Balloon<br />
Dilators<br />
MaxForce TTS Single-Use Balloon Dilators<br />
Passage Single-Use Biliary Dilatation Catheters<br />
Rigiflex® II Single-Use Achalasia Balloon Dilators<br />
C1769 Guide wire<br />
All BSC guide wires used in GI procedures<br />
Hydratome® RX Cannulating Sphincterotomes<br />
Jagtome® RX Cannulating Sphincterotomes<br />
Dreamtome® RX Cannulating Sphincterotomes<br />
C1874 Stent, coated/covered, with delivery system Polyflex® Single-Use Esophageal Stent System<br />
Polyflex® Single-Use Self-Expanding Silicone<br />
Airway Stent System<br />
Ultraflex Single-Use Covered Esophageal NG<br />
Stent System – Proximal Release<br />
Ultraflex Single-Use Covered Large Esophageal<br />
NG Stent System – Proximal Release<br />
Ultraflex Single-Use Covered Large Esophageal<br />
NG Stent System – Distal Release<br />
Ultraflex Single-Use Covered Tracheobronchial<br />
Stent System – Distal Release<br />
WALLSTENT® RX Single-Use Biliary<br />
Endoprosthesis with Permalume® Covering<br />
WALLSTENT® Single-Use Esophageal II<br />
Endoprosthesis with Permalume® Covering and<br />
Unistep Plus Delivery System<br />
WALLSTENT® Single-Use Tracheobronchial<br />
Endoprosthesis with Permalume® Covering and<br />
Unistep® Plus Delivery System<br />
WallFlex® Partially Covered Esophageal Stent<br />
WallFlex® Biliary RX Fully Covered Stent System<br />
WallFlex® Biliary RX Partially Covered Stent<br />
System<br />
WallFlex® Partially Covered Esophageal Stent<br />
System<br />
WallFlex® Fully Covered Esophageal Stent System<br />
C1875 Stent, coated/covered without delivery<br />
system<br />
Dynamic TM (Y) Stent<br />
1<br />
For devices packaged in kits, hospitals may bill for the components of the kits that individually qualify for C-codes. Facilities should bill for<br />
the estimated proportion of the kit that the C-code eligible device comprises<br />
See important notes on the uses and limitations of this information on page 24.<br />
Business Unit Name<br />
Final PSST# MVG16780<br />
Page 2 of 24
C-code C-code Description Devices Impacted 1<br />
C1876 Stent, non-coated/non-covered, with Ultraflex Diamond Single-Use Biliary Stent<br />
delivery system<br />
System<br />
Ultraflex Precision Single-Use Colonic Stent<br />
System<br />
Ultraflex Single-Use Noncovered Esophageal<br />
NG Stent System – Distal Release<br />
Ultraflex Single-Use Noncovered Esophageal<br />
NG Stent System – Proximal Release<br />
Ultraflex Single-Use Noncovered<br />
Tracheobronchial Stent System – Distal Release<br />
Ultraflex Single-Use Noncovered<br />
Tracheobronchial Stent System – Proximal<br />
Release<br />
WALLSTENT® RX Single-Use Biliary<br />
Endoprosthesis<br />
WALLSTENT® Single-Use Biliary Endoprosthesis<br />
WALLSTENT® Single-Use Colonic and Duodenal<br />
Endoprosthesis with Unistep® Plus Delivery<br />
System<br />
WallFlex® Single-Use Colonic Stent System<br />
WallFlex® Single-Use Duodenal Stent System<br />
C2617 Stent, non-coronary, temporary, C-Flex® Single-Use Pigtail Biliary Stent<br />
without delivery system<br />
Percuflex® Amsterdam Single-Use Biliary Stent<br />
Without Introducer Kit<br />
Advanix TM Biliary Stent<br />
Flexima® Single-Use Biliary Stent System<br />
Percuflex® Amsterdam Single-Use Biliary Stent<br />
with Introducer Kits 1<br />
C2625<br />
Stent, non-coronary, temporary, with<br />
delivery system<br />
RX Single-Use Plastic Biliary Stents<br />
Advanix TM Preloaded Biliary Stents<br />
See important notes on the uses and limitations of this information on page 24.<br />
Business Unit Name<br />
1 For devices packaged in kits, hospitals may bill for the components of the kits that individually qualify for C-codes. Facilities<br />
should bill for the estimated proportion of the kit that the C-code eligible device comprises.<br />
Achalasia Balloons<br />
Final PSST# MVG16780<br />
Page 3 of 24
C1726 : Catheter, balloon dilation, non-vascular<br />
Device Name UPN Order # Description CAT Code<br />
Rigiflex® II Single-Use<br />
Achalasia Balloon Dilator<br />
M00554500 5450 Rigiflex II Single Use ABD 30mm C1726<br />
M00554510 5451 Rigiflex II Single Use ABD 35mm C1726<br />
Balloon Dilators<br />
C1726 : Catheter, balloon dilation, non-vascular<br />
See important notes on the uses and limitations of this information on page 24.<br />
Business Unit Name<br />
M00554520 5452 Rigiflex II Single Use ABD 40mm C1726<br />
Device Name UPN Order # Description CAT Code<br />
MaxForce TTS Single-<br />
Use Esophageal Balloon<br />
M00589060 8906 MFTTS/6-6/180 C1726<br />
Dilator<br />
M00589080 8908 MFTTS/8-6/180 C1726<br />
CRE Single-Use Fixed<br />
Wire Balloon Dilators<br />
M00589100 8910 MFTTS/10-6/180 C1726<br />
M00589120 8912 MFTTS/12-6/180 C1726<br />
M00589140 8914 MFTTS/14-6/180 C1726<br />
M00589150 8915 MFTTS/15-6/180 C1726<br />
M00589160 8916 MFTTS/16-6/180 C1726<br />
M00589180 8918 MFTTS/18-6/180 C1726<br />
M00558330 5833 CRE 6-8MM 8CM F/G C1726<br />
M00558340 5834 CRE 8-10MM 8CM F/G C1726<br />
M00558350 5835 CRE 10-12MM 8CM F/G C1726<br />
M00558360 5836 CRE 12-15MM 8CM F/G C1726<br />
M00558370 5837 CRE 15-18MM 8CM F/G C1726<br />
M00558380 5838 CRE 18-20MM 8CM F/G C1726<br />
M00558361 5836 CRE FIXED WIRE 5836-05 C1726<br />
M00558371 5837 CRE FIXED WIRE 5837-05 C1726<br />
M00558381 5838 CRE FIXED WIRE 5838-05 C1726<br />
Final PSST# MVG16780<br />
Page 4 of 24
Balloon Dilators (cont.)<br />
C1726 : Catheter, balloon dilation, non-vascular<br />
See important notes on the uses and limitations of this information on page 24.<br />
Business Unit Name<br />
Device Name UPN Order # Description CAT Code<br />
CRE Single-Use<br />
Wireguided<br />
M00558390 5839 CRE WG 6-8MM/180CM/5.5 F/G C1726<br />
Esophageal/Pyloric Balloon<br />
Dilators<br />
M00558400 5840 CRE WG 8-10MM/180CM/5.5 F/G C1726<br />
M00558410 5841 CRE WG 10-12MM/180CM/5.5 F/G C1726<br />
MaxForce Single-Use<br />
Biliary Dilatation Balloons<br />
Hurricane® RX Single-Use<br />
Biliary Balloon Dilatation<br />
Catheters<br />
M00558420 5842 CRE WG 12-15MM/180CM/5.5 F/G C1726<br />
M00558430 5843 CRE WG 15-18MM/180CM/5.5 F/G C1726<br />
M00558440 5844 CRE WG 18-20MM/180CM/5.5 F/G C1726<br />
M00558450 5845 CRE WG 6-8MM/240CM/5.5 F/G C1726<br />
M00558460 5846 CRE WG 8-10MM/240CM/5.5 F/G C1726<br />
M00558470 5847 CRE WG 10-12MM/240CM/5.5 F/G C1726<br />
M00558480 5848 CRE WG 12-15MM/240CM/5.5 F/G C1726<br />
M00558490 5849 CRE WG 15-18MM/240CM/5.5 F/G C1726<br />
M00558500 5850 CRE WG 18-20MM/240CM/5.5 F/G C1726<br />
M00567330 6733 MaxForce/4-2/5/180 C1726<br />
M00567340 6734 MaxForce/4-4/5/180 C1726<br />
M00567370 6737 MaxForce/6-2/5/180 C1726<br />
M00567380 6738 MaxForce/6-4/5/180 C1726<br />
M00567410 6741 MaxForce/8-2/5/180 C1726<br />
M00567420 6742 MaxForce/8-3/5/180 C1726<br />
M00545890 4589 RX DILATATION BLN 4-2/5.8/180 C1726<br />
M00545900 4590 RX DILATATION BLN 4-4/5.8/180 C1726<br />
M00545910 4591 RX DILATATION BLN 6-2/5.8/180 C1726<br />
M00545920 4592 RX DILATATION BLN 6-4/5.8/180 C1726<br />
M00545930 4593 RX DILATATION BLN 8-2/5.8/180 C1726<br />
M00545940 4594 RX DILATATION BLN 8-4/5.8/180 C1726<br />
M00545950 4595 RX DILATATION BLN 10-2/5.8/180 C1726<br />
M00545960 4596 RX DILATATION BLN 10-4/5.8/180 C1726<br />
Final PSST# MVG16780<br />
Page 5 of 24
Balloon Dilators (cont.)<br />
C1726 : Catheter, balloon dilation, non-vascular<br />
See important notes on the uses and limitations of this information on page 24.<br />
Business Unit Name<br />
Device Name UPN Order # Description CAT Code<br />
CRE Single-Use<br />
Pulmonary Balloon Dilator<br />
M00550300 5030 CRE PULM 5.5CM 12-15MM OD 75CM C1726<br />
M00550310 5031 CRE PULM 5.5CM 15-18MM OD 75CM C1726<br />
G.I. Guidewires<br />
C1769 : Guide wire<br />
M00550320 5032 CRE PULM 5.5CM 18-20MM OD 75CM C1726<br />
M00550330 5033 CRE PULM 3CM 8-10MM OD 75CM C1726<br />
M00550340 5034 CRE PULM 3CM 10-12MM OD 75CM C1726<br />
M00550350 5035 CRE PULM 3CM 12-15MM OD 75CM C1726<br />
Device Name UPN Order # Description CAT Code<br />
Jagwire® Single-Use High<br />
Performance Guidewires<br />
M00556561 5656 JAGWIRE/025/STRAIGHT C1769<br />
M00556581 5658 JAGWIRE/035/STRAIGHT C1769<br />
M00556591 5659 JAGWIRE/035/ANGLED C1769<br />
M00556601 5660 JAGWIRE/035/STRAIGHT STIFF C1769<br />
M00556611 5661 ENDOJAG .035 SS/450 ANG. C1769<br />
M00556461 5646 JAG HINI 025/260 ST C1769<br />
M00556481 5648 JAG HINI 025/260 (SS) ST C1769<br />
M00556491 5649 JAG HINI 025/260 (SS) ANG C1769<br />
M00556621 5662 JAGWIRE/038/260CM STRAIGHT C1769<br />
M00556631 5663 JAGWIRE/035/260CM SS ST C1769<br />
M00556641 5664 JAGWIRE/035/260CM STRAIGHT C1769<br />
M00556651 5665 JAGWIRE/035/260CM ANGLED C1769<br />
M00556661 5666 JAGWIRE/035/260CM SS ANGLED C1769<br />
M00556841 5684 JAGWIRE 035/260 CM STRAIGHT C1769<br />
M00556851 5685 EXTEND JAGWIRE 035/260 CM ANGLED C1769<br />
M00556861 5686 JAGWIRE 035/260 CM SS STRAIGHT C1769<br />
M00556871 5687 EXTEND JAGWIRE 035/260 CM SS ANGLED C1769<br />
M00556902 5690 JAGTAIL /.035/200 CM C1769<br />
Final PSST# MVG16780<br />
Page 6 of 24
G.I. Guidewires (cont.)<br />
C1769 : Guide wire<br />
See important notes on the uses and limitations of this information on page 24.<br />
Business Unit Name<br />
Device Name UPN Order # Description CAT Code<br />
Jagwire® Single-Use<br />
Pulmonary Guidewire<br />
M00515171 1517 PULM JAGWIRE SS 180 cm 0.035 STRGT C1769<br />
Dreamwire® High<br />
Performance Guidewire<br />
Hydra Jagwire® Single-<br />
Use Guidewires<br />
Pathfinder Single-Use<br />
Exchange Guidewire – Stiff<br />
Shaft<br />
M00556101 5610 Dreamwire F/G .035"/Stnd/260cm/STR C1769<br />
M00556111 5611 Dreamwire F/G .035"/Stnd/260cm/ANG C1769<br />
M00556121 5612 Dreamwire F/G .035"/Stiff/260cm/STR C1769<br />
M00556131 5613 Dreamwire F/G .035"/Stiff/260cm/ANG C1769<br />
M00556141 5614 Dreamwire F/G .035"/Stnd/450cm/STR C1769<br />
M00556151 5615 Dreamwire F/G .035"/Stnd/450cm/ANG C1769<br />
M00556161 5616 Dreamwire F/G .035"/Stiff/450cm/STR C1769<br />
M00556171 5617 Dreamwire F/G .035"/Stiff/450cm/ANG C1769<br />
M00556001 5600 Hydra-Jag/.035/260cm/STR C1769<br />
M00556011 5601 Hydra-Jag/.035/260cm/ANG C1769<br />
M00556021 5602 Hydra-Jag/.035/260cm/SS/STR C1769<br />
M00556031 5603 Hydra-Jag/.035/260cm/SS/ANG C1769<br />
M00556041 5604 Hydra-Jag/.035/450cm/STR. C1769<br />
M00556051 5605 Hydra-Jag/.035/450cm/ANG C1769<br />
M00556061 5606 Hydra-Jag/.035/450cm/SS/STR C1769<br />
M00556071 5607 Hydra-Jag/.035/450cm/SS/ANG. C1769<br />
M00551591 5159 PATHFINDER 018/450 C1769<br />
Final PSST# MVG16780<br />
Page 7 of 24
G.I. Guidewires (cont.)<br />
C1769 : Guide wire<br />
See important notes on the uses and limitations of this information on page 24.<br />
Business Unit Name<br />
Device Name UPN Order # Description<br />
CAT<br />
Code<br />
Glidewire® Single-Use<br />
Guidewire<br />
M00551901 5190 GLIDE .035 X 260 ANGLED C1769<br />
M00551911 5191 GLIDE .035 X 260 STRT C1769<br />
Amplatz Super Stiff<br />
Esophageal<br />
WALLSTENT® Super Stiff<br />
Guidewire<br />
Jagtome® RX Cannulating<br />
Sphincterotome (Preloaded<br />
with Jagwire)<br />
M00551961 5196 GLIDE .035 X 260 STRT C1769<br />
M00551971 5197 GLIDE .035 X 260 ANGLED C1769<br />
M00551981 5198 GLIDE .025 X 260 STRT C1769<br />
M00551991 5199 GLIDE .025 X 260 ANGLED C1769<br />
M00551921 5192 GLIDE .035 X 450 ANGLED C1769<br />
M00551931 5193 GLIDE .035 X 450 STRT C1769<br />
M00551941 5194 GLIDE SS 035/450 ANG C1769<br />
M00551951 5195 GLIDE SS 035/450 STRT C1769<br />
M00553401 5340 GLIDE .025 X 450 STRT C1769<br />
M00553411 5341 GLIDE .025 X 450 ANGLED C1769<br />
M00553421 5342 GLIDE .020 X 450 STRT C1769<br />
M00553431 5343 GLIDE .020 X 450 ANGLED C1769<br />
M00550090 5009 MVI ENDO-AMPLATZ SS 038/260 GUIDEWIRE C1769<br />
H965180011 18001 GUIDEWIRE/GI .035 500CM C1769<br />
M00573000 7300 Jagtome RX 49-20-260-035 C1769<br />
M00573010 7301 Jagtome RX 49-20-450-035 C1769<br />
M00573020 7302 Jagtome RX 49-30-260-035 C1769<br />
M00573030 7303 Jagtome RX 49-30-450-035 C1769<br />
Final PSST# MVG16780<br />
Page 8 of 24
G.I. Guidewires (cont.)<br />
C1769 : Guide wire<br />
Device Name UPN Order # Description CAT Code<br />
Hydratome® RX<br />
Cannulating<br />
M00583000 8300 HydraTome RX 49-20mm/260cm C1769<br />
Sphincterotome (Preloaded<br />
with Hydra Jagwire)<br />
M00583010 8301 HydraTome RX 49-30mm/260cm C1769<br />
M00583020 8302 HydraTome RX 49-20mm/450cm C1769<br />
Dreamtome® RX<br />
Cannulating<br />
Sphincterotome<br />
Plastic Biliary Stents<br />
See important notes on the uses and limitations of this information on page 24.<br />
Business Unit Name<br />
M00583030 8303 HydraTome RX 49-30mm/450cm C1769<br />
M00583040 8304 HydraTome RX 44-20mm/260cm C1769<br />
M00583050 8305 HydraTome RX 44-30mm/260cm C1769<br />
M00583060 8306 HydraTome RX 44-20mm/450cm C1769<br />
M00583070 8307 HydraTome RX 44-30mm/450cm C1769<br />
M00584000 8400 Dreamtome 49-20mm/260cm C1769<br />
M00584010 8401 Dreamtome 49-30mm/260cm C1769<br />
M00584020 8402 Dreamtome 49-20mm/450cm C1769<br />
M00584030 8403 Dreamtome 49-30mm/450cm C1769<br />
M00584040 8404 Dreamtome 44-20mm/260cm C1769<br />
M00584050 8405 Dreamtome 44-30mm/260cm C1769<br />
M00584060 8406 Dreamtome 44-20mm/450cm C1769<br />
M00584070 8407 Dreamtome 44-30mm/450cm C1769<br />
C2625: Stent, non-coronary, temporary, with delivery system<br />
Device Name UPN Order # Description CAT Code<br />
Flexima<br />
M00540110 4011 NASAL BILIARY TUBE 5FR C2625<br />
M00540120 4012 NASAL BILIARY TUBE 6FR C2625<br />
® Nasobiliary<br />
Catheter Kit<br />
M00540130 4013 NASAL BIILARY TUBE 7.5FR C2625<br />
M00540140 4014 NASAL BILIARY TUBE 8.5FR C2625<br />
Final PSST# MVG16780<br />
Page 9 of 24
Plastic Biliary Stents (cont.)<br />
C2625: Stent, non-coronary, temporary, with delivery system<br />
Device Name UPN Order # Description CAT Code<br />
Flexima<br />
M00539200 3920 (Flexima) BILIARY STENT 7FR/5CM C2625<br />
M00539210 3921 (Flexima) BILIARY STENT 7FR/7CM C2625<br />
® Single-Use Biliary<br />
Stent System<br />
See important notes on the uses and limitations of this information on page 24.<br />
Business Unit Name<br />
M00539220 3922 (Flexima) BILIARY STENT 7FR/10CM C2625<br />
M00539230 3923 (Flexima) BILIARY STENT 7FR/12CM C2625<br />
M00539240 3924 (Flexima) BILIARY STENT 7FR/15CM C2625<br />
M00539250 3925 (Flexima) BILIARY STENT 8.5FR/5CM C2625<br />
M00539260 3926 (Flexima) BILIARY STENT 8.5FR/7CM C2625<br />
M00539270 3927 (Flexima) BILIARY STENT 8.5FR/10CM C2625<br />
M00539280 3928 (Flexima) BILIARY STENT 8.5FR/12CM C2625<br />
M00539290 3929 (Flexima) BILIARY STENT 8.5FR/15CM C2625<br />
M00539300 3930 (Flexima) BILIARY STENT 10FR/5CM C2625<br />
M00539310 3931 (Flexima) BILIARY STENT 10FR/7CM C2625<br />
M00539320 3932 (Flexima) BILARY STENT 10FR/10CM C2625<br />
M00539330 3933 (Flexima) BILIARY STENT 10FR/12CM C2625<br />
M00539340 3934 (Flexima) BILIARY STENT 10FR/15CM C2625<br />
M00539350 3935 (Flexima) BILIARY STENT 11.5FR/5CM C2625<br />
M00539360 3936 (Flexima) BILIARY STENT 11.5FR/7CM C2625<br />
M00539370 3937 (Flexima) BILIARY STENT 11.5FR/10CM C2625<br />
M00539380 3938 (Flexima) BILIARY STENT 11.5FR/12CM C2625<br />
M00539390 3939 (Flexima) BILIARY STENT 11.5FR/15CM C2625<br />
Final PSST# MVG16780<br />
Page 10 of 24
Plastic Biliary Stents (cont.)<br />
C2625: Stent, non-coronary, temporary, with delivery system<br />
See important notes on the uses and limitations of this information on page 24.<br />
Business Unit Name<br />
Device Name UPN Order # Description CAT Code<br />
Percuflex<br />
M00533760 3376 PERC AMSTER STENT KIT 7FR/5CM C2625<br />
M00533770 3377 PERC AMSTER STENT KIT 7FR/7CM C2625<br />
M00533780 3378 PERC AMSTER STENT KIT 7FR/10CM C2625<br />
® Amsterdam<br />
Single-Use Biliary Stent<br />
with Introducer Kits<br />
w/Push Catheter<br />
RX Single-Use Plastic<br />
Biliary Stent<br />
M00533790 3379 PERC AMSTER STENT KIT 7FR/12CM C2625<br />
M00533800 3380 PERC AMSTER STENT KIT 7FR/15CM C2625<br />
M00533810 3381 PER AMSTER STENT KIT 10FR/5CM C2625<br />
M00533820 3382 PER AMSTER STENT KIT 10FR/7CM C2625<br />
M00533830 3383 PER AMSTER STENT KIT 10FR/10CM C2625<br />
M00533840 3384 PER AMSTER STENT KIT 10FR/12CM C2625<br />
M00533850 3385 PER AMSTER STENT KIT 10FR/15CM C2625<br />
M00545550 4555 RX STENT/7 X 5CM C2625<br />
M00545560 4556 RX STENT/7 X 7CM C2625<br />
M00545570 4557 RX STENT/7 X 10CM C2625<br />
M00545580 4558 RX STENT/7 X 12CM C2625<br />
M00545590 4559 RX STENT/7 X 15CM C2625<br />
M00545600 4560 RX STENT/10 X 5CM C2625<br />
M00545610 4561 RX STENT/10 X 7CM C2625<br />
M00545620 4562 RX STENT/10 X 10CM C2625<br />
M00545630 4563 RX STENT/10 X 12CM C2625<br />
M00545640 4564 RX STENT/10 X 15CM C2625<br />
M00545650 4565 RX STENT/8.5 X 5CM C2625<br />
M00545660 4566 RX STENT/8.5 X 7CM C2625<br />
M00545670 4567 RX STENT/8.5 X 10CM C2625<br />
M00545680 4568 RX STENT/8.5 X 12CM C2625<br />
M00545690 4569 RX STENT/8.5 X 15CM C2625<br />
M00545700 4570 RX STENT/11.5 X 5CM C2625<br />
M00545710 4571 RX STENT/11.5 X 7CM C2625<br />
M00545720 4572 RX STENT/11.5 X 10CM C2625<br />
M00545730 4573 RX STENT/11.5 X 12CM C2625<br />
M00545740 4574 RX STENT/11.5 X 15CM C2625<br />
Final PSST# MVG16780<br />
Page 11 of 24
Plastic Biliary Stents (cont.)<br />
C2625: Stent, non-coronary, temporary, with delivery system<br />
Device Name<br />
Advanix<br />
UPN Order # Description CAT Code<br />
TM Duodenal Bend<br />
Preloaded RX Stent<br />
Systems<br />
M00534200 3420 Advanix Duodenal Bend 7FR X 5CM Business C2625 Unit Name<br />
M00534210 3421 Advanix Duodenal Bend 7FR X 7CM C2625<br />
M00534220 3422 Advanix Duodenal Bend 7FR X 9CM C2625<br />
M00534230 3423 Advanix Duodenal Bend 7FR X 12CM C2625<br />
M00534240 3424 Advanix Duodenal Bend 7FR X 15CM C2625<br />
M00534250 3425 Advanix Duodenal Bend 7FR X 18CM C2625<br />
M00534260 3426 Advanix Duodenal Bend 8.5FR X 5CM C2625<br />
M00534270 3427 Advanix Duodenal Bend 8.5FR X 7CM C2625<br />
M00534280 3428 Advanix Duodenal Bend 8.5FR X 9CM C2625<br />
M00534290 3429 Advanix Duodenal Bend 8.5FR X 12CM C2625<br />
M00534300 3430 Advanix Duodenal Bend 8.5FR X 15CM C2625<br />
M00534310 3431 Advanix Duodenal Bend 8.5FR X 18CM C2625<br />
M00534320 3432 Advanix Duodenal Bend 10FR X 5CM C2625<br />
M00534330 3433 Advanix Duodenal Bend 10FR X 7CM C2625<br />
M00534340 3434 Advanix Duodenal Bend 10FR X 9CM C2625<br />
M00534350 3435 Advanix Duodenal Bend 10FR X 12CM C2625<br />
M00534360 3436 Advanix Duodenal Bend 10FR X 15CM C2625<br />
M00534370 3437 Advanix Duodenal Bend 10FR X 18CM C2625<br />
Device Name UPN Order # Description CAT Code<br />
Advanix TM Center Bend<br />
Preloaded RX Stent<br />
Systems<br />
M00534560 3456 Advanix Center Bend 7FR X 5CM C2625<br />
M00534570 3457 Advanix Center Bend 7FR X 7CM C2625<br />
M00534580 3458 Advanix Center Bend 7FR X 9CM C2625<br />
M00534590 3459 Advanix Center Bend 7FR X 12CM C2625<br />
M00534600 3460 Advanix Center Bend 7FR X 15CM C2625<br />
M00534610 3461 Advanix Center Bend 7FR X 18CM C2625<br />
M00534620 3462 Advanix Center Bend 8.5FR X 5CM C2625<br />
M00534630 3463 Advanix Center Bend 8.5FR X 7CM C2625<br />
M00534640 3464 Advanix Center Bend 8.5FR X 9CM C2625<br />
M00534650 3465 Advanix Center Bend 8.5FR X 12CM C2625<br />
M00534660 3466 Advanix Center Bend 8.5FR X 15CM C2625<br />
M00534670 3467 Advanix Center Bend 8.5FR X 18CM C2625<br />
M00534680 3468 Advanix Center Bend 10FR X 5CM C2625<br />
M00534690 3469 Advanix Center Bend 10FR X 7CM C2625<br />
M00534700 3470 Advanix Center Bend 10FR X 9CM C2625<br />
M00534710 3471 Advanix Center Bend 10FR X 12CM C2625<br />
M00534720 3472 Advanix Center Bend 10FR X 15CM C2625<br />
M00534730 3473 Advanix Center Bend 10FR X 18CM C2625<br />
See important notes on the uses and limitations of this information on page 24.<br />
Final PSST# MVG16780<br />
Page 12 of 24
Plastic Biliary Stents (cont.)<br />
Stent, non-coronary, temporary, without delivery system<br />
Device Name UPN Order # Description CAT Code<br />
Advanix TM Duodenal Bend<br />
Single Stent<br />
M00532870 3287 Advanix Duo Bend-Single 7FR X 5CM<br />
Business Unit Name<br />
C2617<br />
M00532880 3288 Advanix Duo Bend-Single 7FR X 7CM C2617<br />
M00532890 3289 Advanix Duo Bend-Single 7FR X 9CM C2617<br />
M00532900 3290 Advanix Duo Bend-Single 7FR X 12CM C2617<br />
M00532910 3291 Advanix Duo Bend-Single 7FR X 15CM C2617<br />
M00532920 3292 Advanix Duo Bend-Single 7FR X 18CM C2617<br />
M00532930 3293 Advanix Duo Bend-Single 8.5FR X 5CM C2617<br />
M00532940 3294 Advanix Duo Bend-Single 8.5FR X 7CM C2617<br />
M00532950 3295 Advanix Duo Bend-Single 8.5FR X 9CM C2617<br />
M00532960 3296 Advanix Duo Bend-Single 8.5FR X 12CM C2617<br />
M00532970 3297 Advanix Duo Bend-Single 8.5FR X 15CM C2617<br />
M00532980 3298 Advanix Duo Bend-Single 8.5FR X 18CM C2617<br />
M00532990 3299 Advanix Duo Bend-Single 10FR X 5CM C2617<br />
M00533000 3300 Advanix Duo Bend-Single 10FR X 7CM C2617<br />
M00533010 3301 Advanix Duo Bend-Single 10FR X 9CM C2617<br />
M00533020 3302 Advanix Duo Bend-Single 10FR X 12CM C2617<br />
M00533030 3303 Advanix Duo Bend-Single 10FR X 15CM C2617<br />
M00533040 3304 Advanix Duo Bend-Single 10FR X 18CM C2617<br />
Device Name UPN Order # Description CAT Code<br />
Advanix TM Center Bend<br />
Single Stent<br />
M00533230 3323 Advanix Ctr Bend-Single 7FR X 5CM C2617<br />
M00533240 3324 Advanix Ctr Bend-Single 7FR X 7CM C2617<br />
M00533250 3325 Advanix Ctr Bend-Single 7FR X 9CM C2617<br />
M00533260 3326 Advanix Ctr Bend-Single 7FR X 12CM C2617<br />
M00533270 3327 Advanix Ctr Bend-Single 7FR X 15CM C2617<br />
M00533280 3328 Advanix Ctr Bend-Single 7FR X 18CM C2617<br />
M00533290 3329 Advanix Ctr Bend-Single 8.5FR X 5CM C2617<br />
M00533300 3330 Advanix Ctr Bend-Single 8.5FR X 7CM C2617<br />
M00533310 3331 Advanix Ctr Bend-Single 8.5FR X 9CM C2617<br />
M00533320 3332 Advanix Ctr Bend-Single 8.5FR X 12CM C2617<br />
M00533330 3333 Advanix Ctr Bend-Single 8.5FR X 15CM C2617<br />
M00533340 3334 Advanix Ctr Bend-Single 8.5FR X 18CM C2617<br />
M00533350 3335 Advanix Ctr Bend-Single 10FR X 5CM C2617<br />
M00533360 3336 Advanix Ctr Bend-Single 10FR X 7CM C2617<br />
M00533370 3337 Advanix Ctr Bend-Single 10FR X 9CM C2617<br />
M00533380 3338 Advanix Ctr Bend-Single 10FR X 12CM C2617<br />
M00533390 3339 Advanix Ctr Bend-Single 10FR X 15CM C2617<br />
M00533400 3340 Advanix Ctr Bend-Single 10FR X 18CM C2617<br />
See important notes on the uses and limitations of this information on page 24.<br />
Final PSST# MVG16780<br />
Page 13 of 24
Plastic Biliary Stents (Cont.)<br />
C2617: Stent, non-coronary, temporary, without delivery system<br />
Device Name UPN Order # Description CAT Code<br />
M00532160 3216 Advanix Double Pigtail-Single 7FR X 3CM<br />
Business Unit Name<br />
C2617<br />
M00532180 3218 Advanix Double Pigtail-Single 7FR X 5CM C2617<br />
M00532190 3219 Advanix Double Pigtail-Single 7FR X 7CM C2617<br />
M00532210 3221 Advanix Double Pigtail-Single 7FR X 10CM C2617<br />
M00532220 3222 Advanix Double Pigtail-Single 7FR X 12CM C2617<br />
M00532230 3223 Advanix Double Pigtail-Single 7FR X 15CM C2617<br />
M00532240 3224 Advanix Double Pigtail-Single 10FR X 3CM C2617<br />
M00532260 3226 Advanix Double Pigtail-Single 10FR X 5CM C2617<br />
M00532270 3227 Advanix Double Pigtail-Single 10FR X 7CM C2617<br />
M00532290 3229 Advanix Double Pigtail-Single 10FR X 9CM C2617<br />
M00532300 3230 Advanix Double Pigtail-Single 10FR X 12CM C2617<br />
M00532310 3231 Advanix Double Pigtail-Single 10FR X 15CM C2617<br />
Device Name UPN Order # Description CAT Code<br />
Percuflex® Amsterdam<br />
Single-Use Biliary Stent<br />
M00533610 3361 PERC BIL DRAIN STENTS 7FR/5CM C2617<br />
M00533620 3362 PERC BIL DRAIN STENTS 7FR/7CM C2617<br />
M00533630 3363 PERC BIL DRAIN STENTS 7FR/10CM C2617<br />
M00533640 3364 PERC BIL DRAIN STENTS 7FR/12CM C2617<br />
M00533650 3365 PERC BIL DRAIN STENTS 7FR/15CM C2617<br />
M00533660 3366 PERC BIL DRAIN STENT 10FR/5CM C2617<br />
M00533670 3367 PERC BIL DRAIN STENT 10FR/7CM C2617<br />
M00533680 3368 PERC BIL DRAIN STENT 10FR/10CM C2617<br />
M00533690 3369 PERC BIL DRAIN STENT 10FR/12CM C2617<br />
M00533700 3370 PERC BIL DRAIN STENT 10FR/15CM C2617<br />
M00533710 3371 PERC BIL DRAIN STENT 12FR/5CM C2617<br />
M00533720 3372 PERC BIL DRAIN STENT 12FR/7CM C2617<br />
M00533730 3373 PERC BIL DRAIN STENT 12FR/10CM C2617<br />
M00533740 3374 PERC BIL DRAIN STENT 12FR/12CM C2617<br />
M00533750 3375 PERC BIL DRAIN STENT 12FR/15CM C2617<br />
See important notes on the uses and limitations of this information on page 24.<br />
Final PSST# MVG16780<br />
Page 14 of 24
Plastic Biliary Stents (Cont.)<br />
Biliary Bare Metal Stents<br />
C1876: Stent, non-coated/non-covered, with delivery system<br />
See important notes on the uses and limitations of this information on page 24.<br />
Business Unit Name<br />
Device Name UPN Order # Description CAT Code<br />
WALLSTENT® Single-Use<br />
Biliary Endoprosthesis<br />
H965430100 43010 8X40 BLRY ENDO UNI PLUS HALO 7.5F/219CM C1876<br />
H965430200 43020 8X60 BLRY ENDO UNI PLUS HAL0 7.5F/219CM C1876<br />
WALLSTENT® RX Single-<br />
Use Biliary Endoprosthesis<br />
WallFlex® Biliary RX<br />
Uncovered Stent System<br />
C2617: Stent, non-coated/non-covered, with delivery system<br />
Device Name UPN Order # Description CAT Code<br />
C-Flex® Single-Use<br />
Pigtail Biliary Stent<br />
M00532010 3201 PIGTAIL STENT 7/5 C2617<br />
M00532020 3202 PIGTAIL STENT 7/10 C2617<br />
M00532030 3203 PIGTAIL STENT 7/15 C2617<br />
M00532040 3204 PIGTAIL STENT 10/5 C2617<br />
M00532050 3205 PIGTAIL STENT 10/10 C2617<br />
H965430300 43030 8X80 BLRY ENDO UNI PLUS HALO 7.5F/219CM C1876<br />
H965430400 43040 10X40 BLRY ENDO UNI PLUS HALO7.5F/219CM C1876<br />
H965430500 43050 10X60 BLRY ENDO UNI PLUS HALO7.5F/219CM C1876<br />
H965430600 43060 10X80 BLRY ENDO UNI PLUS HALO7.5F/219CM C1876<br />
M00569610 6961 MODEL-RX WS BILIARY 8 X 40 C1876<br />
M00569620 6962 MODEL-RX WS BILIARY 8 X 60 C1876<br />
M00569630 6963 MODEL-RX WS BILIARY 8 X 80 C1876<br />
M00569640 6964 MODEL-RX WS BILIARY 10 X 40 C1876<br />
M00569650 6965 MODEL-RX WS BILIARY 10 X 60 C1876<br />
M00569660 6966 MODEL-RX WS BILIARY 10 X 80 C1876<br />
M00569800 6980 RX WALLSTENT BILIARY 8 X 100 C1876<br />
M00569810 6981 RX WALLSTENT BILIARY 10 X 100 C1876<br />
M00570600 7060 WALLFLEX BILIARY RX UNCOVERED 8X40 C1876<br />
M00570610 7061 WALLFLEX BILIARY RX UNCOVERED 8X60 C1876<br />
M00570620 7062 WALLFLEX BILIARY RX UNCOVERED 8X80 C1876<br />
M00570630 7063 WALLFLEX BILIARY RX UNCOVERED 8X100 C1876<br />
M00570640 7064 WALLFLEX BILIARY RX UNCOVERED 10X60 C1876<br />
M00570650 7065 WALLFLEX BILIARY RX UNCOVERED 10X80 C1876<br />
Final PSST# MVG16780<br />
Page 15 of 24
C1876: Stent, non-coated/non-covered, with delivery system<br />
Device Name UPN Order # Description CAT Code<br />
WallFlex® Biliary RX<br />
Uncovered Stent System<br />
M00570660 7066 WALLFLEX BILIARY RX UNCOVERED 10X100 C1876<br />
M00570890 7089 WALLFLEX BILIARY RX UNCOVERED 10x40 C1876<br />
Biliary Covered Metal Stents<br />
C1874: Stent, coated/covered, with delivery system<br />
See important notes on the uses and limitations of this information on page 24.<br />
Business Unit Name<br />
Device Name UPN Order # Description CAT Code<br />
WALLSTENT® RX Single-<br />
Use Biliary Endoprosthesis<br />
M00569670 6967 MODEL-RX WS PERMALUME 8 X 40 C1874<br />
with Permalume® Covering M00569680 6968 MODEL-RX WS PERMALUME 8 X 60 C1874<br />
WALLSTENT® Single-Use<br />
Biliary Endoprosthesis with<br />
Permalume® Covering<br />
WallFlex® Biliary RX<br />
Covered Stent System<br />
WallFlex® Biliary RX<br />
Partially Covered Stent<br />
System<br />
M00569690 6969 MODEL-RX WL PERMALUME 8 X 80 C1874<br />
M00569700 6970 MODEL-RX WS PERMALUME 10 X 40 C1874<br />
M00569710 6971 MODEL-RX WS PERMALUME 10 X 60 C1874<br />
M00569720 6972 MODEL-RX WS PERMALUME 10 X 80 C1874<br />
H965430700 43070 MODEL CVD ENDO BIL 8FR 8X40 194CM C1874<br />
H965430800 43080 MODEL CVD BIL ENDO/8FR 8X60 194CM C1874<br />
H965430900 43090 MODEL CVD BIL ENDO 8FR 8X80 194CM C1874<br />
H965431000 43100 MODEL CVD BIL ENDO 8FR 10X40 194CM C1874<br />
H965431100 43110 MODEL CVD BIL ENDO 8FR 10X60 194CM C1874<br />
H965431200 43120 MODEL CVD BIL ENDO 8FR 10X80 194CM C1874<br />
M00570500 7050 WALLFLEX BILIARY RX COVERED 8X60 C1874<br />
M00570510 7051 WALLFLEX BILIARY RX COVERED 8X80 C1874<br />
M00570520 7052 WALLFLEX BILIARY RX COVERED 10X40 C1874<br />
M00570530 7053 WALLFLEX BILIARY RX COVERED 10X60 C1874<br />
M00570540 7054 WALLFLEX BILIARY RX COVERED 10X80 C1874<br />
M00570700 7070 WALLFLEX BILIARY RX PARTCOVERED 8x60 C1874<br />
M00570710 7071 WALLFLEX BILIARY RX PARTCOVERED 8x80 C1874<br />
M00570720 7072 WALLFLEX BILIARY RX PARTCOVERED 10x40 C1874<br />
M00570730 7073 WALLFLEX BILIARY RX PARTCOVERED 10x60 C1874<br />
M00570740 7074 WALLFLEX BILIARY RX PARTCOVERED 10x80 C1874<br />
Final PSST# MVG16780<br />
Page 16 of 24
Esophageal Covered Stents<br />
C1874: Stent, coated/covered, with delivery system<br />
Device Name UPN Order # Description CAT Code<br />
Ultraflex Single-Use<br />
Covered Esophageal NG<br />
Stent System – Distal<br />
Release<br />
M00513730<br />
M00513740<br />
M00513750<br />
1373<br />
1374<br />
1375<br />
ULTRAFLEX ESOPH NG DISTL CVD STN 18X10<br />
ULTRAFLEX ESOPH NG DISTL CVD STN 18X12<br />
ULTRAFLEX ESOPH NG DISTL CVD STN 18X15<br />
C1874<br />
C1874<br />
C1874<br />
Polyflex® Single-Use<br />
Esophageal Stent System<br />
WallFlex® Fully Covered<br />
Esophageal Stent System<br />
M00513840 1384 ULTRAFLEX ESOPH NG PROX CVD STN 18X10<br />
M00513850 1385 ULTRAFLEX ESOPH NG PROX CVD STN 18X12<br />
M00513860 1386 ULTRAFLEX ESOPH NG PROX CVD STN 18X15<br />
M00514200 1420 ULTRAFLEX ESOPH NG DST CVD STN 23X10<br />
M00514210 1421 ULTRAFLEX ESOPH NG DST CVD STN 23X12<br />
M00514240 1424 ULTRAFLEX ESOPH NG PROX CVD STN 23X10<br />
M00514250 1425 ULTRAFLEX ESOPH NG PROX CVD STN 23X12<br />
M00514270 1427 POLYFLEX ESOPH 20/16MM X 90MM<br />
M00514280 1428 POLYFLEX ESOPH 20/16MM X 120MM<br />
M00514290 1429 POLYFLEX ESOPH 20/16MM X 150MM<br />
M00514300 1430 POLYFLEX ESOPH 23/18MM X 90MM<br />
M00514310 1431 POLYFLEX ESOPH 23/18MM X 120MM<br />
M00514320 1432 POLYFLEX ESOPH 23/18MM X 150MM<br />
M00514330 1433 POLYFLEX ESOPH 25/21MM X 90MM<br />
M00514340 1434 POLYFLEX ESOPH 25/21MM X 120MM<br />
M00514350 1435 POLYFLEX ESOPH 25/21MM X 150MM<br />
M00516700 1670 WALLFLEX FULLY COVERED ESOPHAGEAL<br />
STENT SYSTEM 18X10<br />
M00516710 1671 WALLFLEX FULLY COVERED ESOPHAGEAL<br />
STENT SYSTEM 18X12<br />
M00516720 1672 WALLFLEX FULLY COVERED ESOPHAGEAL<br />
STENT SYSTEM 18X15<br />
M00516730 1673 WALLFLEX FULLY COVERED ESOPHAGEAL<br />
STENT SYSTEM 23X10<br />
M00516740 1674 WALLFLEX FULLY COVERED ESOPHAGEAL<br />
STENT SYSTEM 23X12<br />
M00516750 1675 WALLFLEX FULLY COVERED ESOPHAGEAL<br />
STENT SYSTEM 23X15<br />
See important notes on the uses and limitations of this information on page 24.<br />
Business Unit Name<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
Final PSST# MVG16780<br />
Page 17 of 24
Esophageal Covered Stents (cont.)<br />
C1874: Stent, non-coated/non-covered, with delivery system<br />
Device Name UPN Order # Description CAT Code<br />
WallFlex® Partially<br />
Covered Esophageal Stent<br />
System<br />
M00516900<br />
M00516920<br />
1690<br />
1692<br />
WALLFLEX PC ESOPH STENT 18/23mm x 103mm<br />
WALLFLEX PC ESOPH STENT 18/23mm x 153mm<br />
C1874<br />
C1874<br />
Esophageal Bare Metal Stents<br />
M00516930 1693 WALLFLEX PC ESOPH STENT 23/28mm x 105mm<br />
M00516910 1691 WALLFLEX PC ESOPH STENT 18/23mm x 123mm<br />
M00516940 1694 WALLFLEX PC ESOPH STENT 23/28mm x 125mm<br />
M00516950 1695 WALLFLEX PC ESOPH STENT 23/28mm x 155mm<br />
C1876: Stent, non-coated/non-covered, with delivery system<br />
See important notes on the uses and limitations of this information on page 24.<br />
Business Unit Name<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
Device Name UPN Order # Description CAT Code<br />
Ultraflex Single-Use<br />
Noncovered Esophageal<br />
NG Stent System – Distal<br />
Release<br />
M00513700<br />
M00513710<br />
M00513720<br />
1370<br />
1371<br />
1372<br />
ULTRAFLEX ESOPH NG DISTL UNCVD STN 18X7<br />
ULTRAFLEX ESOPH NG DISTL UNCVD STN<br />
18X10<br />
ULTRAFLEX ESOPH NG DISTL UNCVD STN<br />
18X15<br />
C1876<br />
C1876<br />
C1876<br />
M00513800 1380 ULTRAFLEX ESOPH NG PROX UNCVD STN 18X7 C1876<br />
M00513810 1381<br />
M00513830 1383<br />
Colonic and Duodenal Bare Metal Stents<br />
C1876: Stent, non-coated/non-covered, with delivery system<br />
ULTRAFLEX ESOPH NG PROX UNCVD STN<br />
18X10<br />
ULTRAFLEX ESOPH NG PROX UNCVD STN<br />
18X15<br />
C1876<br />
C1876<br />
Device Name UPN Order # Description CAT Code<br />
WALLSTENT® Single-Use<br />
Colonic and Duodenal<br />
M00565560 6556 MODEL-ENTERAL NG 10FR 20x60/230CM C1876<br />
Endoprosthesis with<br />
Unistep® Plus Delivery<br />
M00565570 6557 MODEL-ENTERAL NG 10FR 20x90/230CM C1876<br />
System<br />
M00565580 6558 MODEL-ENTERAL NG 10FR 22x60/230CM C1876<br />
M00565590 6559 MODEL-ENTERAL NG 10FR 22x90/230CM C1876<br />
M00565620 6562 MODEL-ENTERAL NG 10FR 20x60/135CM C1876<br />
M00565630 6563 MODEL-ENTERAL NG 10FR 20x90/135CM C1876<br />
M00565640 6564 MODEL-ENTERAL NG 10FR 22x60/135CM C1876<br />
M00565650 6565 MODEL-ENTERAL NG 10FR 22x90/135CM C1876<br />
Final PSST# MVG16780<br />
Page 18 of 24
Colo Colonic and Duodenal Bare Metal Stents (cont.)nic and Duodenal Bare Stents (cont.)<br />
C1876: Stent, non-coated/non-covered, with delivery system<br />
See important notes on the uses and limitations of this information on page 24.<br />
Business Unit Name<br />
Device Name UPN Order # Description CAT Code<br />
Ultraflex Precision<br />
Single-Use Colonic Stent<br />
System<br />
M00557330<br />
M00557360<br />
5733<br />
5736<br />
1M COLONIC 25/30X6 UNCOV PROX<br />
1M COLONIC 25/30X9 UNCOV PROX<br />
C1876<br />
C1876<br />
M00557380 5738 1M COLONIC 25/30X12 UNCOV PROX<br />
C1876<br />
WallFlex® Single-Use<br />
Duodenal Stent System<br />
WallFlex® Single-Use<br />
Colonic Stent System<br />
M00565010 6501 WALLFLEX ENTERAL DUODENAL 27/22X 6<br />
230CM<br />
M00565020 6502 WALLFLEX ENTERAL DUODENAL 27/22X 9<br />
230CM<br />
M00565030 6503 WALLFLEX ENTERAL DUODENAL 27/22X 12<br />
230CM<br />
M00565040 6504 WALLFLEX ENTERAL COLONIC 30/25 X 6 230CM<br />
M00565050 6505 WALLFLEX ENTERAL COLONIC 30/25 X 96<br />
230CM<br />
M00565060 6506 WALLFLEX ENTERAL COLONIC 30/25 X 12<br />
230CM<br />
M00565070 6507 WALLFLEX ENTERAL COLONIC 30/25 X 6 135CM<br />
M00565080 6508 WALLFLEX ENTERAL COLONIC 30/25 X 96<br />
135CM<br />
M00565090 6509 WALLFLEX ENTERAL COLONIC 30/25 X 12<br />
135CM<br />
M00565100 6510 WALLFLEX ENTERAL COLONIC 27/22 X 6 230CM<br />
M00565110 6511 WALLFLEX ENTERAL COLONIC 27/22 X 96<br />
230CM<br />
M00565120 6512 WALLFLEX ENTERAL COLONIC 27/22 X 12<br />
230CM<br />
M00565130 6513 WALLFLEX ENTERAL COLONIC 27/22 X 6 135CM<br />
M00565140 6514 WALLFLEX ENTERAL COLONIC 27/22 X 96<br />
135CM<br />
M00565150 6515 WALLFLEX ENTERAL COLONIC 27/22 X 12<br />
135CM<br />
C1876<br />
C1876<br />
C1876<br />
C1876<br />
C1876<br />
C1876<br />
C1876<br />
C1876<br />
C1876<br />
C1876<br />
C1876<br />
C1876<br />
C1876<br />
C1876<br />
C1876<br />
Final PSST# MVG16780<br />
Page 19 of 24
Pulmonary Bare Stents<br />
C1876: Stent, non-coated/non-covered, with delivery system<br />
Device Name UPN Order # Description CAT Code<br />
Ultraflex Single-Use<br />
Noncovered<br />
M00569070 6907 UP/10-3/16/95 C1876<br />
Tracheobronchial Stent<br />
System – Distal Release<br />
M00569080 6908 UP/12-3/16/95 C1876<br />
Bronchial Stents<br />
M00569090 6909 UP/14-3/16/95 C1876<br />
Ultraflex Single-Use<br />
Noncovered<br />
Tracheobronchial Stent<br />
System – Proximal<br />
Release – Bronchial Stents<br />
See important notes on the uses and limitations of this information on page 24.<br />
Business Unit Name<br />
M00569230 6923 UP/16-4/16/95 C1876<br />
M00569240 6924 UP/16-6/16/95 C1876<br />
M00569250 6925 UP/16-8/16/95 C1876<br />
M00569260 6926 UP/18-4/16/95 C1876<br />
M00569270 6927 UP/18-6/16/95 C1876<br />
M00569280 6928 UP/18-8/16/95 C1876<br />
M00569290 6929 UP/20-4/16/95 C1876<br />
M00569300 6930 UP/20-6/16/95 C1876<br />
M00569310 6931 UP/20-8/16/95 C1876<br />
M00568920 6892 UP/8-2/16/95<br />
M00568930 6893 UP/8-4/16/95<br />
M00568940 6894 UP/10-2/16/95<br />
M00568950 6895 UP/10-4/16/95<br />
M00568960 6896 UP/12-2/16/95<br />
M00568970 6897 UP/12-4/16/95<br />
M00568980 6898 UP/14-2/16/95<br />
M00569920 6992 UP/14-4/16/95<br />
M00569930 6993 UP/14-6/16/95<br />
C1876<br />
C1876<br />
C1876<br />
C1876<br />
C1876<br />
C1876<br />
C1876<br />
C1876<br />
C1876<br />
Final PSST# MVG16780<br />
Page 20 of 24
Pulmonary Covered Stents<br />
C1874: Stent, non-coated/non-covered, with delivery system<br />
Device Name UPN Order # Description CAT Code<br />
Ultraflex Single-Use<br />
Covered Tracheobronchial<br />
M00569040 6904 UPC/14-3/16/95, 1.5CM COVER C1874<br />
Stent System – Distal<br />
Release Bronchial Stents<br />
M00569050 6905 UPC/10-3/16/95, 1.5CM COVER C1874<br />
M00569060 6906 UPC/12-3/16/95, 1.5CM COVER C1874<br />
See important notes on the uses and limitations of this information on page 24.<br />
Business Unit Name<br />
M00569410 6941 UPC/8-4/16/95, 2.5CM COVER C1874<br />
M00569430 6943 UPC/10-4/16/95, 2.5CM COVER C1874<br />
M00569450 6945 UPC/12-4/16/95, 2.5CM COVER C1874<br />
M00569480 6948 UPC/14-4/16/95, 2.5CM COVER C1874<br />
M00569490 6949 UPC/14-6/16/95, 4.5CM COVER C1874<br />
M00569500 6950 UPC/14-8/16/95, 6.5CM COVER C1874<br />
M00569510 6951 UPC/16-4/16/95, 2.5CM COVER C1874<br />
M00569520 6952 UPC/16-6/16/95, 4.5CM COVER C1874<br />
M00569530 6953 UPC/16-8/16/95, 6.5CM COVER C1874<br />
M00569540 6954 UPC/18-4/16/95, 2.5CM COVER C1874<br />
M00569550 6955 UPC/18-6/16/95, 4.5CM COVER C1874<br />
M00569560 6956 UPC/18-8/16/95, 6.5CM COVER C1874<br />
M00569570 6957 UPC/20-4/16/95, 2.5CM COVER C1874<br />
M00569580 6958 UPC/20-6/16/95, 4.5CM COVER C1874<br />
M00569590 6959 UPC/20-8/16/95, 6.5CM COVER C1874<br />
Final PSST# MVG16780<br />
Page 21 of 24
Pulmonary Covered Stents (cont.)<br />
C1874: Stent, non-coated/non-covered, with delivery system<br />
Device Name UPN Order # Description CAT Code<br />
Polyflex® Single-Use Self-<br />
Expanding Silicone Airway<br />
Stent System<br />
M00570000<br />
M00570010<br />
7000<br />
7001<br />
POLYFLEX AIRWAY 8MM IDX20MM OD 7MM<br />
POLYFLEX AIRWAY 8MM IDX30MM OD 7MM<br />
C1874<br />
C1874<br />
M00570020 7002 POLYFLEX AIRWAY 10MM IDX20MM OD 8MM<br />
M00570030 7003 POLYFLEX AIRWAY 10MM IDX30MM OD 8MM<br />
M00570040 7004 POLYFLEX AIRWAY 10MM IDX40MM OD 8MM<br />
M00570050 7005 POLYFLEX AIRWAY 10MM IDX50MM OD 8MM<br />
M00570060 7006 POLYFLEX AIRWAY 12MM IDX20MM OD 9MM<br />
M00570070 7007 POLYFLEX AIRWAY 12MM IDX30MM OD 9MM<br />
M00570080 7008 POLYFLEX AIRWAY 12MM IDX40MM OD 9MM<br />
M00570090 7009 POLYFLEX AIRWAY 12MM IDX50MM OD 9MM<br />
M00570100 7010 POLYFLEX AIRWAY 14MM IDX20MM OD 9MM<br />
M00570110 7011 POLYFLEX AIRWAY 14MM IDX30MM OD 9MM<br />
M00570120 7012 POLYFLEX AIRWAY 14MM IDX40MM OD 9MM<br />
M00570130 7013 POLYFLEX AIRWAY 14MM IDX50MM OD 9MM<br />
M00570140 7014 POLYFLEX AIRWAY 14MM IDX60MM OD 9MM<br />
M00570150 7015 POLYFLEX AIRWAY 16MM IDX30MM OD 10MM<br />
M00570160 7016 POLYFLEX AIRWAY 16MM IDX40MM OD 10MM<br />
M00570170 7017 POLYFLEX AIRWAY 16MM IDX50MM OD 10MM<br />
M00570180 7018 POLYFLEX AIRWAY 16MM IDX60MM OD 10MM<br />
M00570190 7019 POLYFLEX AIRWAY 16MM IDX70MM OD 10MM<br />
M00570200 7020 POLYFLEX AIRWAY 18MM IDX30MM OD 11MM<br />
M00570210 7021 POLYFLEX AIRWAY 18MM IDX40MM OD 11MM<br />
M00570220 7022 POLYFLEX AIRWAY 18MM IDX50MM OD 11MM<br />
M00570230 7023 POLYFLEX AIRWAY 18MM IDX60MM OD 11MM<br />
M00570240 7024 POLYFLEX AIRWAY 18MM IDX70MM OD 11MM<br />
M00570250 7025 POLYFLEX AIRWAY 18MM IDX80MM OD 11MM<br />
M00570260 7026 POLYFLEX AIRWAY 20MM IDX40MM OD 12MM<br />
M00570270 7027 POLYFLEX AIRWAY 20MM IDX50MM OD 12MM<br />
See important notes on the uses and limitations of this information on page 24.<br />
Business Unit Name<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
Final PSST# MVG16780<br />
Page 22 of 24
Pulmonary Covered Stents (cont.)<br />
C1874: Stent, non-coated/non-covered, with delivery system<br />
Device Name UPN Order # Description CAT Code<br />
Polyflex® Single-Use Self-<br />
Expanding Silicone Airway<br />
Stent System (cont.)<br />
M00570280<br />
M00570290<br />
7028<br />
7029<br />
POLYFLEX AIRWAY 20MM IDX60MM OD 12MM<br />
POLYFLEX AIRWAY 20MM IDX70MM OD 12MM<br />
C1874<br />
C1874<br />
C1875: Stent, coated/ covered, without delivery system<br />
M00570300 7030 POLYFLEX AIRWAY 20MM IDX80MM OD 12MM<br />
M00570310 7031 POLYFLEX AIRWAY 22MM IDX50MM OD 13MM<br />
M00570320 7032 POLYFLEX AIRWAY 22MM IDX60MM OD 13MM<br />
M00570330 7033 POLYFLEX AIRWAY 22MM IDX80MM OD 13MM<br />
See important notes on the uses and limitations of this information on page 24.<br />
Business Unit Name<br />
C1874<br />
C1874<br />
C1874<br />
C1874<br />
Device Name UPN Order # Description CAT Code<br />
Dynamic (Y) STENT<br />
M00570670 7067 Dynamic (Y) Stent 11/8mm, 110/25/40 C1875<br />
M00570680 7068 Dynamic (Y) Stent 13/10mm, 110/25/40 C1875<br />
M00570690 7069 Dynamic (Y) Stent 15/12mm, 110/25/40 C1875<br />
Final PSST# MVG16780<br />
Page 23 of 24
* As of January 1, 2005, the Centers for Medicare and Medicaid Services (CMS) requires hospitals to report all device category<br />
codes (C-codes) on Medicare outpatient claims when medical devices are used in conjunction with procedure(s) billed. If C-codes<br />
are not identified on submitted Medicare outpatient claims, the claims(s) will be returned to the hospital for correction. Find<br />
C-codes for <strong>Endoscopy</strong> products at<br />
http://www.bostonscientific.com/templatedata/imports/collateral/Reimbursement/<strong>Endoscopy</strong>/2009%20Guides%20(use%20this%20folder)/2009<br />
%20C-Code%20Cross%20Reference%20Guide.pdf<br />
Also find C-codes for <strong>Endoscopy</strong> products at<br />
http://www.cms.hhs.gov/HospitalOutpatientPPS/Downloads/DeviceCats_OPPSUpdate.pdf or http://<br />
www.cms.hhs.gov/HospitalOutpatientPPS/04 passthrough payment.asp#TopOfPage<br />
** Modifier -26 (professional component) is for physician billing only. See the AMA’s Current Procedural Terminology 2008 for<br />
complete descriptions.<br />
Current Procedural Terminology ©2010 American Medical Association. All Rights Reserved.<br />
Glidewire is a trademark of Terumo Kabushiki Kaisha.<br />
C-Flex is a trademark of Saint-Gobain Performance Plastics Corporation<br />
CPT Disclaimer<br />
CPT Copyright 2010 American Medical Association. All rights reserved. CPT is a registered trademark of the American<br />
Medical Association.<br />
Applicable FARS/DFARS Restrictions Apply to Government Use. Fee schedules, relative value units, conversion<br />
factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not<br />
recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The<br />
AMA assumes no liability for data contained or not contained herein.<br />
See important notes on the uses and limitations of this information on page 24.<br />
<strong>Boston</strong> <strong>Scientific</strong> Corporation<br />
One <strong>Boston</strong> <strong>Scientific</strong> Place<br />
Natick, MA 01760-1537<br />
www.bostonscientific.com<br />
Business Unit Name<br />
©2011 <strong>Boston</strong> <strong>Scientific</strong> Corporation<br />
or its affiliates. All rights reserved.<br />
PSST# MVG16780<br />
Final PSST# MVG16780<br />
Page 24 of 24
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