VerifyNow System

Basic Information

• Brand Name: VerifyNow System
• Primary DI: 10711234500170
• Version / Model: 86000RF
• Catalog Number: 86000RF
• Company Name: ACCRIVA DIAGNOSTICS HOLDINGS, INC.
• Labeler DUNS: 079299318
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 5
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: fe4412f4-6c6b-4cfa-8b98-82815694e670

Device Description

VerifyNow System (Refurbished)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JOZ	System, Automated Platelet Aggregation	Hematology	864.5700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56699	Platelet aggregation analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro examination of platelet function in a clinical specimen, by inducing platelet aggregation through the addition of platelet aggregating agents. The instrument may incorporate various technologies including electrical impedance, photometry, turbidimetry and/or luminescence together with sample processing, data processing and/or data display software.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10711234500170	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K992531	000