DEVICE: VerifyNow Platelet Reactivity Test (10711234150078)

Device Identifier (DI) Information

VerifyNow Platelet Reactivity Test
85225
In Commercial Distribution
85225
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
10711234150078
GS1

25
079299318 *Terms of Use
VerifyNow PRUTest 25/box
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Platelet aggregation study 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 qualitative evaluation of platelet aggregation in a clinical specimen using one or multiple platelet aggregation agents, which may include adenosine diphosphate, collagen, epinephrine, thrombin, arachidonic acid and/or ristocetin.
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FDA Product Code

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Product Code Product Code Name
JOZ System, Automated Platelet Aggregation
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K141427 000
No CLOSE

Sterilization

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

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Storage and Handling
Storage Environment Temperature: between 59 and 77 Degrees Fahrenheit
Storage Environment Temperature: between 15 and 25 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

4f7d6478-a93b-4e12-aabd-64798cf3de3d
July 06, 2018
3
September 22, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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Unit of Use DI Number: 00711234150071 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1-800-643-1640
UDI@accriva.com
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