DEVICE: ASEPT® (04046964317293)
Device Identifier (DI) Information
ASEPT®
622281
In Commercial Distribution
622281
B BRAUN INTERVENTIONAL SYSTEMS, INC
622281
In Commercial Distribution
622281
B BRAUN INTERVENTIONAL SYSTEMS, INC
2,000 ML DRAINAGE BAG W PROCEDURE PACK
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
62850 | Wound drainage bag |
A plastic pouch designed to be attached with an adhesive to the skin around a large wound or fistula and intended to be used as a receptacle for exudate, blood, or other bodily wastes. It is a one-piece device, supplied in a variety of sizes, with a large-area adhesive flange that can be cut to fit closely around a wound, and which may provide some skin protection. It may have a tubular outlet and be connected to a drain system; it does not include accessory devices (i.e., not a kit). This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FMH | CONTAINER, SPECIMEN, STERILE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: |
Special Storage Condition, Specify: Store at room temp |
Special Storage Condition, Specify: Keep away from sunlight |
Special Storage Condition, Specify: KEEP DRY |
Clinically Relevant Size
[?]Size Type Text |
---|
Total Volume: 2000.0 Milliliter |
Device Record Status
004dda29-a202-48b0-aceb-8d9ae42999b2
September 11, 2023
6
August 09, 2016
September 11, 2023
6
August 09, 2016
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 |
Unit of Use DI
[?]
Unit of Use DI Number:
04046964317279
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(877)836-2228
GUDID.BBMUS_Service@bbraun.com
GUDID.BBMUS_Service@bbraun.com