George King Factor IX Deficient Plasma

GUDID 00815696020009

George King Factor IX Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor IX Deficient donors

GEORGE KING BIO-MEDICAL, INC

Coagulation factor IX IVD, reagent
Primary Device ID00815696020009
NIH Device Record Key36885626-7a34-4312-94b3-0f31399ac0c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameGeorge King Factor IX Deficient Plasma
Version Model Number0900-1.0
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
GS100815696020009 [Primary]

FDA Product Code

GJTPlasma, Coagulation Factor Deficient

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 Date2016-07-11

On-Brand Devices [George King Factor IX Deficient Plasma]

00815696021013George King Factor IX Deficient Plasma is fresh frozen citrated human plasma derived from congen
00815696021006George King Factor IX Deficient Plasma is fresh frozen citrated human plasma derived from congen
00815696020610George King Factor IX Deficient Plasma is fresh frozen citrated human plasma derived from congen
00815696020306George King Factor IX Deficient Plasma is fresh frozen citrated human plasma derived from congen
00815696020221George King Factor IX Deficient Plasma is fresh frozen citrated human plasma derived from congen
00815696020214George King Factor IX Deficient Plasma is fresh frozen citrated human plasma derived from congen
00815696020009George King Factor IX Deficient Plasma is fresh frozen citrated human plasma derived from congen

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