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Avoximeter Whole Blood Oximeter

FDA UDI

Class II (US FDA UDI)

by Accriva Diagnostics Holdings, Inc.

Identity

Trade Name
Avoximeter Whole Blood Oximeter FDA UDI
Generic Name
Co-oximetry analyser IVD, point-of-care FDA UDI
Device Name
Avoximeter Whole Blood Oximeter System - Instrument FDA UDI
Model / Reference
AVOX1000E FDA UDI
Description
Avoximeter Whole Blood Oximeter System - Instrument FDA UDI

Identifiers

Catalog Number
AVOX1000E FDA UDI
Primary DI / UDI-DI
10711234530023 FDA UDI
510(k) Number
K922075 FDA UDI
FDA Product Code
DQA FDA UDI
GMDN Term
Co-oximetry analyser IVD, point-of-care FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2700 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Co-oximetry analyser IVD, point-of-care

Avoximeter Whole Blood Oximeter by Accriva Diagnostics Holdings, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Co-oximetry analyser IVD, point-of-care.

Cleared under the same submission

K922075 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Accriva Diagnostics Holdings, Inc.

Sources (1)

  • FDA UDI 679af065-b078-4bf1-93ba-ebaefb1fb147 36 fields · synced May 31, 2026