VerifyNow System 85021

GUDID 10711234500095

VerifyNow Printer Kit

ACCRIVA DIAGNOSTICS HOLDINGS, INC.

Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD, semi-automated Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD Platelet aggregation analyser IVD

• Primary Device ID: 10711234500095
• NIH Device Record Key: 1beca0b0-c6c1-44e4-ba1f-b5c385d38770
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VerifyNow System
• Version Model Number: 85021
• Catalog Number: 85021
• Company DUNS: 079299318
• Company Name: ACCRIVA DIAGNOSTICS HOLDINGS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10711234500095 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992531

FDA Product Code

• JOZ: System, Automated Platelet Aggregation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-14
• Device Publish Date: 2021-04-06

On-Brand Devices [VerifyNow System]

• 10711234500095: VerifyNow Printer Kit
• 10711234500170: VerifyNow System (Refurbished)
• 10711234500163: VerifyNow System (Demonstration)
• 10711234500156: VerifyNow System (Loaner)
• 10711234500149: VerifyNow System (Demonstration)
• 10711234500132: VerifyNow System (Loaner)
• 10711234500118: VerifyNow System (Serviced)
• 10711234500040: VerifyNow System
• 10711234150122: VerifyNow System Electronic Quality Control Device
• 10711234150115: VerifyNow System Preventative Maintenance Kit
• 10711234150108: VerifyNow System Validation Kit
• 10711234150092: VerifyNow WQC 6/box