AccessGUDID - DEVICE: George King Congential Factor Deficiency Convenience Kit (00815696021037)

GUDID

Device Identifier (DI) Information

Brand Name: George King Congential Factor Deficiency Convenience Kit
Version or Model: 0055-5
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GEORGE KING BIO-MEDICAL, INC

Primary DI Number: 00815696021037
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 066761271 *Terms of Use

Device Description: George King CFD is a Congenital Factor Deficient Convenience Kit which contains five different factor deficient plasma's for product evaluation

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:	Yes
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?
56047	Coagulation factor XII IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of coagulation factor XII in a clinical specimen.	Active	false
56042	Coagulation factor XI IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of coagulation factor XI in a clinical specimen.	Active	false
56037	Coagulation factor X IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of coagulation factor X in a clinical specimen.	Active	false
56250	Coagulation factor IX IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of coagulation factor IX in a clinical specimen.	Active	false
56247	Coagulation factor VII IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of coagulation factor VII in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GJT	Plasma, Coagulation Factor Deficient

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: 89a1184f-a034-4f1d-9ead-8dd27ae0b197
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: March 20, 2017