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Nonin

FDA UDI

Class II (US FDA UDI)

by Nonin Medical, Inc.

Identity

Trade Name
Nonin FDA UDI
Generic Name
Pulse oximeter FDA UDI
Device Name
Onyx Vantage Finger Pulse Oximeter, Blue FDA UDI
Model / Reference
9590 FDA UDI
Description
Onyx Vantage Finger Pulse Oximeter, Blue FDA UDI

Identifiers

Primary DI / UDI-DI
00849686072785 FDA UDI
FDA Product Code
DQA FDA UDI
GMDN Term
Pulse oximeter 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

No

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

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Pulse oximeter

Nonin by Nonin Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pulse oximeter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nonin Medical, Inc.

Sources (1)

  • FDA UDI cfc31b5d-d5f6-4b94-a4f1-6031ff2a563b 36 fields · synced Jun 9, 2026