AccessGUDID - DEVICE: ASEPT (04046964317330)

GUDID

Device Identifier (DI) Information

Brand Name: ASEPT
Version or Model: 622284
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 622284
Company Name: B BRAUN INTERVENTIONAL SYSTEMS, INC

Primary DI Number: 04046964317330
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 784259751 *Terms of Use

Device Description: ASEPT PERITONEAL DRAINAGE SYSTEM

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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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

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Product Code	Product Code Name
FJS	CATHETER, PERITONEAL, LONG-TERM INDWELLING

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K093796	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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

Public Device Record Key: 030a9ca2-7f31-4bdb-b2e1-6f4bf0d30bbd
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: July 26, 2015