DEVICE: George King Factor XIII Deficient Plasma (00815696021150)
Device Identifier (DI) Information
George King Factor XIII Deficient Plasma
1300-250.0
In Commercial Distribution
GEORGE KING BIO-MEDICAL, INC
1300-250.0
In Commercial Distribution
GEORGE KING BIO-MEDICAL, INC
George King Factor XIII Deficient plasma is fresh frozen human plasma derived from a congenital Factor XIII deficient donor.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
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? |
---|---|---|---|---|
60499 | Coagulation factor XIII A subunit IVD, control |
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of coagulation factor XIII A subunit in a clinical specimen.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GGC | Control, Plasma, Abnormal |
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: -70 degrees or lower |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
fc38770a-b08e-4043-b5dd-2217f5ccd90b
April 06, 2020
1
March 27, 2020
April 06, 2020
1
March 27, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
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