DEVICE: George King Coumadin® Plasma (00815696021280)
Device Identifier (DI) Information
George King Coumadin® Plasma
4000-200.0
In Commercial Distribution
GEORGE KING BIO-MEDICAL, INC
4000-200.0
In Commercial Distribution
GEORGE KING BIO-MEDICAL, INC
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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55985 | Prothrombin time (PT) IVD, control |
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of the prothrombin time (PT) of a clinical specimen, with or without standardization to the international normalized ratio (INR).
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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GGN | Plasma, Coagulation Control |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: -70C or colder |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
3c9ca7f6-435d-43ac-899f-f295d079d918
January 28, 2022
1
January 20, 2022
January 28, 2022
1
January 20, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-255-5108
plasma@kingbiomed.com
plasma@kingbiomed.com