← Back to catalogue

Nonin

FDA UDI

Class II (US FDA UDI)

by Nonin Medical, Inc.

Identity

Trade Name
Nonin FDA UDI
Generic Name
Cerebral oximeter sensor, single-use FDA UDI
Device Name
Single-Patient Use, Non-Sterile, Disposable Regional Oximetry Sensor with EQUANOX™ Technology FDA UDI
Model / Reference
8004CB FDA UDI
Description
Single-Patient Use, Non-Sterile, Disposable Regional Oximetry Sensor with EQUANOX™ Technology FDA UDI

Identifiers

Primary DI / UDI-DI
00849686074758 FDA UDI
510(k) Number
K090807 FDA UDI
K132402 FDA UDI
FDA Product Code
MUD FDA UDI
GMDN Term
Cerebral oximeter sensor, single-use 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

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Cerebral oximeter sensor, single-use

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

Similar devices

Also classified as Cerebral oximeter sensor, single-use.

Cleared under the same submission

K090807 also covers:

K132402 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Nonin Medical, Inc.

Sources (1)

  • FDA UDI 0c356c50-a1ff-47e2-b750-1fd7046868f5 37 fields · synced Jun 9, 2026