George King Factor XIII Deficient Plasma

GUDID 00815696020986

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

GEORGE KING BIO-MEDICAL, INC

Coagulation factor XIII A subunit IVD, control
Primary Device ID00815696020986
NIH Device Record Keyff8412b0-d9ff-4019-b8bf-094ee0e7fddd
Commercial Distribution StatusIn Commercial Distribution
Brand NameGeorge King Factor XIII Deficient Plasma
Version Model Number1300-100.0
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
GS100815696020986 [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 Date2016-08-22

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

00815696020986George King Factor XIII Deficient Plasma is fresh frozen citrated human plasma derived from a co
00815696020955George King Factor XIII Deficient Plasma is fresh frozen citrated human plasma derived from a co
00815696020344George King Factor XIII Deficient plasma is fresh frozen citrated human plasma derived from a co
00815696020337George King Factor XIII Deficient plasma is fresh frozen citrated human plasma derived from a co
00815696020320George King Factor XIII Deficient plasma is fresh frozen citrated human plasma derived from a co
00815696021150George King Factor XIII Deficient plasma is fresh frozen human plasma derived from a congenital

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