DEVICE: ASEPT (04046964317330)

Device Identifier (DI) Information

ASEPT
622284
In Commercial Distribution
622284
B BRAUN INTERVENTIONAL SYSTEMS, INC
04046964317330
GS1

1
784259751 *Terms of Use
ASEPT PERITONEAL DRAINAGE SYSTEM
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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
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.
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FDA Product Code

[?]
Product Code Product Code Name
FJS CATHETER, PERITONEAL, LONG-TERM INDWELLING
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

030a9ca2-7f31-4bdb-b2e1-6f4bf0d30bbd
March 29, 2018
2
July 26, 2015
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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: No Unit of Use DI Numbers Found 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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