AccessGUDID - DEVICE: VerifyNow Platelet Reactivity Test (10711234150030)

GUDID

Device Identifier (DI) Information

Brand Name: VerifyNow Platelet Reactivity Test
Version or Model: 85310
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 85310
Company Name: ACCRIVA DIAGNOSTICS HOLDINGS, INC.

Primary DI Number: 10711234150030
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 079299318 *Terms of Use

Device Description: VerifyNow IIb/IIIa Test 10/box

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
56092	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOZ	System, Automated Platelet Aggregation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K013596	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 64 and 77 Degrees Fahrenheit
Storage Environment Temperature: between 18 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 019fb7e9-f4bc-4a56-be78-dc74ced6cf34
Public Version Date: August 31, 2022
Public Version Number: 4
DI Record Publish Date: September 22, 2016