Avoximeter Whole Blood Oximeter C100B

GUDID 10711234160022

Avoximeter 1000E Cuvettes 100 cuvettes/box

ACCRIVA DIAGNOSTICS HOLDINGS, INC.

Multiple blood gas analyte IVD, reagent Multiple blood gas analyte IVD, reagent Multiple blood gas analyte IVD, reagent Multiple blood gas analyte IVD, reagent Multiple blood gas analyte IVD, reagent Multiple blood gas analyte IVD, reagent Multiple blood gas analyte IVD, reagent Multiple blood gas analyte IVD, reagent Multiple blood gas analyte IVD, reagent Multiple blood gas analyte IVD, reagent Multiple blood gas analyte IVD, reagent Multiple blood gas analyte IVD, reagent Multiple blood gas analyte IVD, reagent Multiple blood gas analyte IVD, reagent

• Primary Device ID: 10711234160022
• NIH Device Record Key: 8e69b3e0-2c7b-43a1-97e3-87c01fc4eaad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avoximeter Whole Blood Oximeter
• Version Model Number: C100B
• Catalog Number: C100B
• Company DUNS: 079299318
• Company Name: ACCRIVA DIAGNOSTICS HOLDINGS, INC.
• Device Count: 100
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00711234160025 [Unit of Use]
GS1	10711234160022 [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)