George King Coumadin® Plasma - George King Coumadin® Plasma is citrated fresh - GEORGE KING BIO-MEDICAL, INC

Duns Number:066761271

Device Description: George King Coumadin® Plasma is citrated fresh frozen human plasma derived from donors sta 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.

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More Product Details

Catalog Number

-

Brand Name

George King Coumadin® Plasma

Version/Model Number

4000 - 1.5

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

GGN

Product Code Name

Plasma, Coagulation Control

Device Record Status

Public Device Record Key

5a3a2e5b-e3a5-441a-aa17-f98f0cb0d24a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 19, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GEORGE KING BIO-MEDICAL, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 120