Avoximeter Whole Blood Oximeter E-QCYO

GUDID 10711234160015

Avoximeter Whole Blood Oximeter Optical QC Filters

ACCRIVA DIAGNOSTICS HOLDINGS, INC.

Co-oximetry analyser IVD, point-of-care

• Primary Device ID: 10711234160015
• NIH Device Record Key: 13f1e21a-9776-45de-8457-8d9d70ccf4bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avoximeter Whole Blood Oximeter
• Version Model Number: E-QCYO
• Catalog Number: E-QCYO
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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	10711234160015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K922075

FDA Product Code

• DQA: Oximeter

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 Oximeter]

• 10711234530160: Avoximeter Whole Blood Oximeter System - Instrument Refurbished
• 10711234530146: Avoximeter Whole Blood Oximeter System - Instrument (Loaner)
• 10711234530023: Avoximeter Whole Blood Oximeter System - Instrument
• 10711234160022: Avoximeter 1000E Cuvettes 100 cuvettes/box
• 10711234160015: Avoximeter Whole Blood Oximeter Optical QC Filters
• 10711234530153: Avoximeter Whole Blood Oximeter System - Instrument (Demonstration)