AccessGUDID - DEVICE_ Drägersorb 800 plus (5L) (04048675000020)

2/10/23, 1:58 PM AccessGUDID - DEVICE: Drägersorb 800 plus (5L) (04048675000020)
DEVICE: Drägersorb 800 plus (5L) (04048675000020)
DEVICE IDENTIFIER (DI) INFORMATION
Brand Name: Drägersorb 800 plus (5L)
Version or Model: MX00001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Drägerwerk AG & Co. KGaA
Device Description: No description.
Primary DI Number: 04048675000020
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 315578914 *Terms of Use
DEVICE CHARACTERISTICS
What MRI safety information does the labeling contain?
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):
Device labeled as "Not made with natural rubber latex":
For Single-Use:
Prescription Use (Rx):
Over the Counter (OTC):
Kit:
Combination Product:
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):
MR Unsafe
No
No
Yes
No
No
No
No
No
GMDN
GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name
Carbon dioxide absorber, single-use
GMDN Definition
A non-sterile, prefilled, sealed container (i.e., a canister with
connectors) that constitutes a complete anaesthesia
absorber, which is intended to be placed in an anaesthesia
unit/workstation breathing circuit for the removal of carbon
dioxide (CO2) exhaled by the patient. It is filled by the
manufacturer with an appropriate carbon dioxide absorbent
(e.g., granules of treated soda lime) to chemically remove
CO2. A drain may be included to channel water accumulated
from expired-gas moisture or other source. This is a singleuse
device.
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2/10/23, 1:58 PM AccessGUDID - DEVICE: Drägersorb 800 plus (5L) (04048675000020)
FDA PRODUCT CODE
Product Code
CBL
Product Code Name
Absorbent, Carbon-Dioxide
FDA PREMARKET SUBMISSION
FDA Premarket Submission Number
Supplement Number
Premarket Submission Number Not Available/Not Released
Device Exempt from Premarket Submission: Yes
STERILIZATION
Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No
Sterilization Method
No Sterilization Methods Found
STORAGE AND HANDLING
Storage and Handling
No storage/handling found
CLINICALLY RELEVANT SIZE
Size Type Text
No Device Sizes
DEVICE RECORD STATUS
Public Device Record Key: 3db02117-fa07-4393-9120-01d4fd57da86
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 24, 2015
ALTERNATIVE AND ADDITIONAL IDENTIFIERS ADDITIONAL IDENTIFIERS
PACKAGE DI
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
SECONDARY DI
Issuing Agency
Secondary DI Number
No Secondary DIs found
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2/10/23, 1:58 PM AccessGUDID - DEVICE: Drägersorb 800 plus (5L) (04048675000020)
UNIT OF USE DI
Unit of Use DI Number: 04048675419969
DIRECT MARKING (DM)
Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
PRODUCTION IDENTIFIER(S) IN UDI
Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No
CUSTOMER CONTACT
Phone: +494518820
Email: info@draeger.com
https://accessgudid.nlm.nih.gov/devices/04048675000020 3/3