George King Coumadin® Plasma

GUDID 00815696020146

George King Coumadin® Plasma is citrated fresh frozen human plasma derived from donors stabilized on Coumadin® therapy and is intended for use as a control in the quantitative determination of the INR using the clottable prothrombin time assay.

GEORGE KING BIO-MEDICAL, INC

Prothrombin time (PT) IVD, control
Primary Device ID00815696020146
NIH Device Record Key2db27c4e-a9c8-4b06-b451-84e8c2541dbb
Commercial Distribution StatusIn Commercial Distribution
Brand NameGeorge King Coumadin® Plasma
Version Model Number4000 - 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100815696020146 [Primary]

FDA Product Code

GGNPlasma, Coagulation Control

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 Coumadin® Plasma]

00815696020429George King Coumadin® Plasma is citrated fresh frozen human plasma derived from donors stabiliz
00815696020146George King Coumadin® Plasma is citrated fresh frozen human plasma derived from donors stabiliz
00815696021136George King Coumadin® Plasma is citrated fresh frozen human plasma derived from donors stabiliz
00815696021129George King Coumadin® Plasma is citrated fresh frozen human plasma derived from donors stabiliz
00815696021280George King Coumadin® Plasma is citrated fresh frozen human plasma derived from donors stabiliz

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