DEVICE: HemosIL Liquid Heparin (08426950472476)

Device Identifier (DI) Information

HemosIL Liquid Heparin
00020300100
Not in Commercial Distribution
00020300100
INSTRUMENTATION LABORATORY COMPANY
08426950472476
GS1
March 09, 2018
1
557223252 *Terms of Use
HemosIL Liquid Heparin
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
Yes
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?
56195 Heparin anti-Xa IVD, kit, chromogenic
A collection of reagents and other associated materials intended to be used for the quantitative detection of heparin by measuring its ability to inhibit the activity of activated factor X (factor Xa) in a clinical specimen, using a chromogenic method. The assay is typically used to monitor anticoagulation therapy.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KFF ASSAY, HEPARIN
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K090209 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 reagents are 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

ae544904-cc1b-4f26-8ec7-c4bdd1cb3116
July 13, 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: 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

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