Avoximeter Whole Blood CO-Oximeter AVOX4000

GUDID 10711234530054

Avoximeter Whole Blood CO-Oximeter System - Instrument

ACCRIVA DIAGNOSTICS HOLDINGS, INC.

Co-oximetry analyser IVD, point-of-care

• Primary Device ID: 10711234530054
• NIH Device Record Key: a750aa02-0df8-4aec-a0f1-647a6e76b83c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avoximeter Whole Blood CO-Oximeter
• Version Model Number: AVOX4000
• Catalog Number: AVOX4000
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• 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	10711234530054 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951485

FDA Product Code

• JKS: Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-08-31
• Device Publish Date: 2016-09-22

On-Brand Devices [Avoximeter Whole Blood CO-Oximeter]

• 10711234530276: Avoximeter Whole Blood CO-Oximeter System - Instrument Refurbished
• 10711234530252: Avoximeter Whole Blood CO-Oximeter System - Instrument (Demonstration)
• 10711234530245: Avoximeter Whole Blood CO-Oximeter System - Instrument (Loaner)
• 10711234530054: Avoximeter Whole Blood CO-Oximeter System - Instrument
• 10711234160053: Avoximeter 4000 Cuvettes 100 cuvettes/box
• 10711234160046: Avoximeter Whole Blood CO-Oximeter Temperature Probe
• 10711234160039: Avoximeter Whole Blood CO-Oximeter Optical QC Filters