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Avoximeter Whole Blood CO-Oximeter

FDA UDI

Class I (US FDA UDI)

by Accriva Diagnostics Holdings, Inc.

Identity

Trade Name
Avoximeter Whole Blood CO-Oximeter FDA UDI
Generic Name
Co-oximetry analyser IVD, point-of-care FDA UDI
Device Name
Avoximeter Whole Blood CO-Oximeter Temperature Probe FDA UDI
Model / Reference
4-TMPB FDA UDI
Description
Avoximeter Whole Blood CO-Oximeter Temperature Probe FDA UDI

Identifiers

Catalog Number
4-TMPB FDA UDI
Primary DI / UDI-DI
10711234160046 FDA UDI
510(k) Number
K951485 FDA UDI
FDA Product Code
JKS FDA UDI
GMDN Term
Co-oximetry analyser IVD, point-of-care FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.3220 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

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

Avoximeter Whole Blood CO-Oximeter by Accriva Diagnostics Holdings, Inc. — Class I — 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

K951485 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 5516b6cf-3f76-4a6d-a6ac-7e4859515a64 36 fields · synced May 30, 2026