DEVICE: ASEPT® (04046964317255)

Device Identifier (DI) Information

ASEPT®
622280
In Commercial Distribution
622280
B BRAUN INTERVENTIONAL SYSTEMS, INC
04046964317255
GS1

10
784259751 *Terms of Use
2,000 ML ASEPT DRAINAGE BAG
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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
Wound drainage bag, non-sterile A non-sterile 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 may be connected to a drain system. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
FMH CONTAINER, SPECIMEN, STERILE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: ROOM TEMP AWAY FROM SUNLIGHT
Special Storage Condition, Specify: KEEP DRY
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 2000.0 Milliliter
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Device Record Status

5e061116-47f9-4018-9279-193b29a8f73c
March 29, 2018
2
August 09, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 04046964317231 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(877)836-2228
GUDID.BBMUS_Service@bbraun.com
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