DEVICE: HemosIL Factor X Deficient Plasma (10 X 1 mL) (08426950491385)

Device Identifier (DI) Information

HemosIL Factor X Deficient Plasma (10 X 1 mL)
00020010000
In Commercial Distribution
00020010000
INSTRUMENTATION LABORATORY COMPANY
08426950491385
GS1

10
557223252 *Terms of Use
HemosIL Factor X Deficient Plasma (10 X 1 mL)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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?
56034 Coagulation factor X IVD, kit, clotting
A collection of reagents and other associated materials intended to be used for the quantitative measurement of coagulation factor X in a clinical specimen, using a clotting method.
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 [?]
K031122 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Unopened deficient plasma is stable until the expiration date shown on the vial when stored at 2-8°C.
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

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

50c20abf-ac69-4e95-b55a-96b68cdf65bd
July 14, 2021
5
September 23, 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: 18426950491382 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1-800-678-0710
techsupport.na@werfen.com
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