AccessGUDID - DEVICE: George King Coumadin® Plasma Convenience Kit (00815696021099)

GUDID

Device Identifier (DI) Information

Brand Name: George King Coumadin® Plasma Convenience Kit
Version or Model: 0090-30
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: GEORGE KING BIO-MEDICAL, INC

Primary DI Number: 00815696021099
Issuing Agency: GS1
Commercial Distribution End Date: August 04, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 066761271 *Terms of Use

Device Description: The George King Coumadin® Plasma Kit is a convenience control kit that contains citrated human fresh frozen plasma from donors on Coumadin® therapy. Each kit contains control material with six different INR levels.

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?
55985	Prothrombin time (PT) IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of the prothrombin time (PT) of a clinical specimen, with or without standardization to the international normalized ratio (INR).	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: No 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: 30631cd2-1023-4562-b122-013527d5b15c
Public Version Date: August 07, 2023
Public Version Number: 3
DI Record Publish Date: July 24, 2017