Avoximeter Whole Blood CO-Oximeter 4-QCYO

GUDID 10711234160039

Avoximeter Whole Blood CO-Oximeter Optical QC Filters

ACCRIVA DIAGNOSTICS HOLDINGS, INC.

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Primary Device ID	10711234160039
NIH Device Record Key	45a55bdf-71aa-4faf-a536-9d62db6ad0aa
Commercial Distribution Status	In Commercial Distribution
Brand Name	Avoximeter Whole Blood CO-Oximeter
Version Model Number	4-QCYO
Catalog Number	4-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	10711234160039 [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