AccessGUDID - DEVICE: Blood Administration Set (04046964302664)

GUDID

Device Identifier (DI) Information

Brand Name: Blood Administration Set
Version or Model: 490133
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 490133
Company Name: B. BRAUN MEDICAL INC.

Primary DI Number: 04046964302664
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 002397347 *Terms of Use

Device Description: BLOOD SET W/ 2 HF STOPCOCKS & ULTRASITE

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
Blood transfusion set	A sterile, intravascular administration set used to administer blood from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device typically includes a needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, a stopcock, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an intravenous (IV) bag or other infusion fluid container. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Blood transfusion set

A sterile, intravascular administration set used to administer blood from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device typically includes a needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, a stopcock, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an intravenous (IV) bag or other infusion fluid container. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
FMG	Stopcock, i.V. Set
FPA	Set, administration, intravascular

FDA Premarket Submission

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

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

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b11b479d-7e02-4c23-9362-4e7741b32949
Public Version Date: August 03, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016