George King Factor VIII Deficient Plasma with Inhibitor

GUDID 00815696020627

George King Factor VIII Deficient plasma with Inhibitor is fresh frozen citrated human plasma derived from a congenital Factor VIII deficient donor who has developed an antibody to FVIII.

GEORGE KING BIO-MEDICAL, INC

Coagulation factor VIII inhibitor IVD, control
Primary Device ID00815696020627
NIH Device Record Key6f506498-0244-4685-a76f-8e7b0d46a85d
Commercial Distribution StatusIn Commercial Distribution
Brand NameGeorge King Factor VIII Deficient Plasma with Inhibitor
Version Model Number1800-1.0
Company DUNS066761271
Company NameGEORGE KING BIO-MEDICAL, INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-255-5108
Emailplasma@kingbiomed.com
Phone1-800-255-5108
Emailplasma@kingbiomed.com
Phone1-800-255-5108
Emailplasma@kingbiomed.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *-70˚C or below

Device Identifiers

Device Issuing AgencyDevice ID
GS100815696020627 [Primary]

FDA Product Code

GGCControl, Plasma, Abnormal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-18

On-Brand Devices [George King Factor VIII Deficient Plasma with Inhibitor]

00815696020733George King Factor VIII Deficient plasma with Inhibitor is fresh frozen citrated human plasma de
00815696020627George King Factor VIII Deficient plasma with Inhibitor is fresh frozen citrated human plasma de
00815696021181George King Factor VIII Deficient Plasma with Inhibitor is fresh frozen citrated human plasma de
00815696021174George King Factor VIII Deficient Plasma with Inhibitor is fresh frozen citrated human plasma de
00815696021167George King Factor VIII Deficient Plasma with Inhibitor is fresh frozen citrated human plasma de

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