George King FVII Deficient Plasma

GUDID 00815696021082

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

GEORGE KING BIO-MEDICAL, INC

Coagulation factor VII IVD, reagent
Primary Device ID00815696021082
NIH Device Record Keyb73c4cfc-aa32-41dc-934a-a0e486291d27
Commercial Distribution StatusIn Commercial Distribution
Brand NameGeorge King FVII Deficient Plasma
Version Model Number0070-250.0 mL
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
GS100815696021082 [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 Date2017-06-26

On-Brand Devices [George King FVII Deficient Plasma]

00815696021082George King Factor FVII Deficient Plasma is fresh frozen citrated human plasma derived from cong
00815696021075George King Factor FVII Deficient Plasma is fresh frozen citrated human plasma derived from cong

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