George King Factor X Deficient Plasma

GUDID 00815696020993

George King Factor X Deficient Plasma is a fresh frozen citrated human plasma derived from congenital Factor X deficient donors.

GEORGE KING BIO-MEDICAL, INC

Coagulation factor X IVD, reagent Coagulation factor X IVD, reagent Coagulation factor X IVD, reagent
Primary Device ID00815696020993
NIH Device Record Keyb5b8f0b8-19fe-4ed5-90fc-b45f6cc7bb55
Commercial Distribution StatusIn Commercial Distribution
Brand NameGeorge King Factor X Deficient Plasma
Version Model Number1000-5.0
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
GS100815696020993 [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 Date2016-08-19

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

00815696020993George King Factor X Deficient Plasma is a fresh frozen citrated human plasma derived from conge
00815696020931George King Factor X Deficient Plasma is fresh frozen citrated human plasma derived from congeni
00815696020788George King Factor X Deficient Plasma is fresh frozen citrated human plasma derived from congeni
00815696020771George King Factor X Deficient Plasma is fresh frozen citrated human plasma derived from congeni
00815696020764George King Factor X Deficient Plasma is fresh frozen citrated human plasma derived from congeni
00815696020757George King Factor X Deficient Plasma is fresh frozen citrated human plasma derived from congeni
00815696020061George King Factor X Deficient Plasma is fresh frozen citrated human plasma derived from congeni

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