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CO-Pilot™ Wireless Handheld Multi-Parameter System

FDA UDI

Class II (US FDA UDI)

by Nonin Medical, Inc.

Identity

Trade Name
CO-Pilot™ Wireless Handheld Multi-Parameter System FDA UDI
Generic Name
Pulse oximeter FDA UDI
Device Name
Carrying Case FDA UDI
Model / Reference
H500-CC FDA UDI
Description
Carrying Case FDA UDI

Identifiers

Catalog Number
114079-001 FDA UDI
Primary DI / UDI-DI
00849686051032 FDA UDI
510(k) Number
K192900 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

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Pulse oximeter

CO-Pilot™ Wireless Handheld Multi-Parameter System by Nonin Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pulse oximeter.

Cleared under the same submission

K192900 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 d6401c86-2aa0-4e6e-b6f2-07f1637b5797 35 fields · synced Jun 9, 2026