AccessGUDID - DEVICE: B.BRAUN (04046964290169)

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Device Identifier (DI) Information

Brand Name: B.BRAUN
Version or Model: 4113
Catalog Number: 4113
Company Name: B.Braun Avitum AG

Primary DI Number: 04046964290169
Issuing Agency: GS1
Device Count: 4

Device Description: HELP ACETATE BUFFER 4.85 US 3000ML

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":	No
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
Apheresis kit	A collection of sterile and disposable/consumable devices intended to be used to prepare for and perform (connect the patient) an apheresis treatment (e.g., immunoadsorption, plasmapheresis, plasma exchange) with an apheresis system. It typically consists of tubing, separation devices (e.g., adsorber, filter), and rinsing solutions for preparation of the extracorporeal circuit. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Apheresis kit

A collection of sterile and disposable/consumable devices intended to be used to prepare for and perform (connect the patient) an apheresis treatment (e.g., immunoadsorption, plasmapheresis, plasma exchange) with an apheresis system. It typically consists of tubing, separation devices (e.g., adsorber, filter), and rinsing solutions for preparation of the extracorporeal circuit. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
MMY	LIPOPROTEIN, LOW DENSITY, REMOVAL

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 4 and 25 Degrees Celsius

Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Acidity (pH) : 4.850 PH
Device Size Text, specify: Volume : 3000.000 ML

Device Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: January 18, 2017
Commercial Distribution End Date:

Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

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Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

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DEVICE: B.BRAUN (04046964290169)