DEVICE: ASEPT® (04046964317200)
Device Identifier (DI) Information
ASEPT®
622279
In Commercial Distribution
622279
B BRAUN INTERVENTIONAL SYSTEMS, INC
622279
In Commercial Distribution
622279
B BRAUN INTERVENTIONAL SYSTEMS, INC
ASEPT 1000ML BOTTLE W/ 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? |
---|---|---|---|---|
11301 | Closed-wound/centesis drainage receptacle |
A sterile container designed to be connected to an invasive drain/drainage catheter (not included) to collect fluids or purulent material being removed during drainage of a body cavity, a closed-wound, and/or the bile duct; it is not intended for drainage of cerebrospinal fluid (CSF) or blood. It is typically in the form of a bottle, bag, or bulb with fluid volume markers, and might include a hand-operated pump (e.g., suction bulb) and tubing; it does not include any invasive components or powered devices. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DWM | APPARATUS, SUCTION, PATIENT CARE |
KDQ | BOTTLE, COLLECTION, VACUUM |
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 DRY |
Special Storage Condition, Specify: Store at room temp |
Special Storage Condition, Specify: Keep away from sunlight |
Special Storage Condition, Specify: |
Clinically Relevant Size
[?]Size Type Text |
---|
Total Volume: 1000.0 Milliliter |
Device Record Status
04c2375c-c5dc-4af4-b933-a335ad066d87
September 07, 2023
7
August 09, 2016
September 07, 2023
7
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:
04046964317187
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