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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 probe, reusable FDA UDI
Device Name
Soft Sensor Medium FDA UDI
Model / Reference
8100SM FDA UDI
Description
Soft Sensor Medium FDA UDI

Identifiers

Primary DI / UDI-DI
00849686073386 FDA UDI
510(k) Number
K132402 FDA UDI
FDA Product Code
DQA FDA UDI
GMDN Term
Pulse oximeter probe, reusable 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Pulse oximeter probe, reusable

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

Similar devices

Also classified as Pulse oximeter probe, reusable.

Cleared under the same submission

K132402 also covers:

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 65abde55-d549-4294-bad3-0dcec7cfaf6e 37 fields · synced Jun 9, 2026