DEVICE: George King Factor IX Deficient Plasma (00815696020009)

Device Identifier (DI) Information

George King Factor IX Deficient Plasma
0900-1.0
In Commercial Distribution

GEORGE KING BIO-MEDICAL, INC
00815696020009
GS1

1
066761271 *Terms of Use
George King Factor IX Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor IX Deficient donors
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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?
56250 Coagulation factor IX IVD, reagent
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of coagulation factor IX in a clinical specimen.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GJT Plasma, Coagulation Factor Deficient
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: -70˚C or below
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

36885626-7a34-4312-94b3-0f31399ac0c7
March 29, 2018
2
July 11, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1-800-255-5108
plasma@kingbiomed.com
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