DEVICE: ASEPT® (04046964317101)
Device Identifier (DI) Information
ASEPT®
622272
Not in Commercial Distribution
622272
B BRAUN INTERVENTIONAL SYSTEMS, INC
622272
Not in Commercial Distribution
622272
B BRAUN INTERVENTIONAL SYSTEMS, INC
ASEPT 600ML BOTTLE W/O DRAIN LINE
Device Characteristics
Labeling does not contain MRI Safety Information | |
Yes | |
No | |
Yes | |
Yes | |
No | |
No | |
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? |
---|---|---|---|---|
35824 | Closed-wound drainage kit |
A collection of devices designed to remove fluids or purulent material from a closed-wound in a controlled manner. It includes a container (the receptacle or reservoir), drains/catheters, connectors, a grasping device and possibly a trocar for placing the drains/catheters into the site. The reservoir will usually be provided with graduated markers along its side to facilitate the approximate measurement of the collected fluids. This is a single-use device.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JCX | APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K001716 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: KEEP DRY |
Special Storage Condition, Specify: |
Special Storage Condition, Specify: Store at room temp |
Clinically Relevant Size
[?]Size Type Text |
---|
Total Volume: 600.0 Milliliter |
Device Record Status
11982ee6-fdb6-459c-9179-e4b32ea402a7
September 07, 2023
6
August 09, 2016
September 07, 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:
04046964317088
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