AccessGUDID - DEVICE: B.BRAUN (04046964319860)

GUDID

Device Identifier (DI) Information

Brand Name: B.BRAUN
Version or Model: 7061188
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7061188
Company Name: B.Braun Avitum AG

Primary DI Number: 04046964319860
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 80
Labeler D-U-N-S® Number*: 343689704 *Terms of Use

Device Description: H.E.L.P. Heparin Sodium Solution 30 mL

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P940016	000
P940016	013

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
Storage Environment Temperature: between 4 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Concentration (IU/ml) : 10000.000 IE3
Device Size Text, specify: Volume : 30.000 ML

Device Record Status

Public Device Record Key: 2deb3915-6b22-492c-951c-4955831f6f61
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 18, 2017