AccessGUDID - DEVICE: George King von Willebrand Plasma, Type 2B (00815696021266)

GUDID

Device Identifier (DI) Information

Brand Name: George King von Willebrand Plasma, Type 2B
Version or Model: 1402-50.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GEORGE KING BIO-MEDICAL, INC

Primary DI Number: 00815696021266
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 066761271 *Terms of Use

Device Description: George King von Willebrand plasma, Type 2B, is a citrated human fresh frozen plasma derived from a donor diagnosed with vWD Type 2B. This plasma is intended for use as a control in the quantitative determination of von Willebrand factor antigen in citrated plasma.

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
56029	Coagulation factor VIII-associated antigen IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of coagulation factor VIII-associated antigen, also known as von Willebrand antigen, in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GGN	Plasma, Coagulation Control

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: -70 C or below

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c0dfe136-d340-4e43-83d6-feab8a67cfc7
Public Version Date: April 05, 2021
Public Version Number: 1
DI Record Publish Date: March 26, 2021