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Nonin Pulse Oximeter

FDA UDI

Class II (US FDA UDI)

by Whip-Mix Corp.

Identity

Trade Name
Nonin Pulse Oximeter FDA UDI
Generic Name
Pulse oximeter probe, reusable FDA UDI
Device Name
A small wrist-worn device indicated for use in measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients. FDA UDI
Model / Reference
20012132 FDA UDI
Description
A small wrist-worn device indicated for use in measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients. FDA UDI

Identifiers

Catalog Number
20012132 FDA UDI
Primary DI / UDI-DI
D040200121321 FDA UDI
510(k) Number
K102350 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
Not 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Nonin Pulse Oximeter by Whip-Mix Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K102350 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Whip-Mix Corp.

Sources (1)

  • FDA UDI 83667eda-ae6f-4138-9e7e-ac9bc39d363a 36 fields · synced Jun 6, 2026