AccessGUDID - DEVICE: George King Heparin Control Plasma (00815696021327)

GUDID

Device Identifier (DI) Information

Brand Name: George King Heparin Control Plasma
Version or Model: 7000-1.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GEORGE KING BIO-MEDICAL, INC

Primary DI Number: 00815696021327
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 066761271 *Terms of Use

Device Description: George King (GK) Heparin Control Plasma is an assayed citrated plasma intended for the control of Unfractionated Heparin (UFH) activity using an anti-Xa chromogenic assay and coagulation analyzer with appropriate commercial anti-Xa reagents.

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?
56273	Heparin anti-Xa IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative monitoring of heparin anticoagulant therapy by determining its ability to inhibit the activity of activated factor X (factor Xa) 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: 991b1f90-e435-4aa7-b416-f04ab5e89c32
Public Version Date: July 21, 2025
Public Version Number: 1
DI Record Publish Date: July 11, 2025