AccessGUDID - DEVICE: George King Factor VIII Deficient Plasma with Inhibitor (00815696021181)

GUDID

Device Identifier (DI) Information

Brand Name: George King Factor VIII Deficient Plasma with Inhibitor
Version or Model: 1800-50
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GEORGE KING BIO-MEDICAL, INC

Primary DI Number: 00815696021181
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 066761271 *Terms of Use

Device Description: George King Factor VIII Deficient Plasma with Inhibitor is fresh frozen citrated human plasma derived from a congenital Factor VIII deficient donor whohas developed an antibody to FVIII.

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?
56171	Coagulation factor VIII inhibitor IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of coagulation factor VIII inhibitor 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: -70C or below

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: eada0030-00cd-4804-9ba4-d4e0617d623a
Public Version Date: September 18, 2019
Public Version Number: 1
DI Record Publish Date: September 10, 2019