AccessGUDID - DEVICE: George King Prekallikrein Deficient Plasma (00815696020092)

GUDID

Device Identifier (DI) Information

Brand Name: George King Prekallikrein Deficient Plasma
Version or Model: 1700-1.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GEORGE KING BIO-MEDICAL, INC

Primary DI Number: 00815696020092
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 066761271 *Terms of Use

Device Description: George King Prekallikrein Deficient plasma is fresh frozen citrated human plasma derived from congenital Prekallikrein Deficient donors

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?
56072	Coagulation factor prekallikrein/kallikrein 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 prekallikrein or kallikrein, also known as Fletcher factor, in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GGC	Control, Plasma, Abnormal

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: 5735d0e4-841d-4768-a26d-4519e048d405
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 18, 2016