DEVICE: ASEPT (04046964317330)
Device Identifier (DI) Information
ASEPT
622284
In Commercial Distribution
622284
B BRAUN INTERVENTIONAL SYSTEMS, INC
622284
In Commercial Distribution
622284
B BRAUN INTERVENTIONAL SYSTEMS, INC
ASEPT PERITONEAL DRAINAGE SYSTEM
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Peritoneal drainage catheter | A sterile flexible tube designed for percutaneous insertion into the peritoneal space typically to drain ascites and abdominal abscesses. It may include disposable devices dedicated to catheter introduction, however it does not include any fluid collection bags/containers. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FJS | CATHETER, PERITONEAL, LONG-TERM INDWELLING |
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: KEEP AWAY FROM SUNLIGHT. |
Special Storage Condition, Specify: ROOM TEMP |
Special Storage Condition, Specify: KEEP DRY |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
030a9ca2-7f31-4bdb-b2e1-6f4bf0d30bbd
March 29, 2018
2
July 26, 2015
March 29, 2018
2
July 26, 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 |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
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