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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 oximetry telemetric monitoring system FDA UDI
Device Name
WristOx2 Wearable Pulse Oximeter with Bluetooth FDA UDI
Model / Reference
3150 FDA UDI
Description
WristOx2 Wearable Pulse Oximeter with Bluetooth FDA UDI

Identifiers

Primary DI / UDI-DI
00849686073782 FDA UDI
FDA Product Code
DQA FDA UDI
GMDN Term
Pulse oximetry telemetric monitoring system 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

No

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 oximeterPulse oximetry telemetric monitoring system

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

Similar devices

Also classified as Pulse oximetry telemetric monitoring system.

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 bf8712ee-f5fc-4e77-a0db-dfb7f7176366 35 fields · synced Jun 9, 2026