AccessGUDID - DEVICE: George King B-FACT (00815696020573)

GUDID

Device Identifier (DI) Information

Brand Name: George King B-FACT
Version or Model: 0040-1.5
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: GEORGE KING BIO-MEDICAL, INC

Primary DI Number: 00815696020573
Issuing Agency: GS1
Commercial Distribution End Date: April 01, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 066761271 *Terms of Use

Device Description: George King B-FACT is a borderline normal fresh frozen citrated control that is used to verify the performance of an assay intended to be used for the quantitative determination of multiple coagulation factors, intermediates and/or activated components.

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?
30590	Multiple coagulation factor IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components 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 [?]
K945854	000

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: cd3f7f85-812a-4b1d-948c-3f98e1ccde89
Public Version Date: April 03, 2023
Public Version Number: 5
DI Record Publish Date: August 17, 2016