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NuvoMed

FDA UDI

Class II (US FDA UDI)

by Nuvomed Inc

Identity

Trade Name
NuvoMed FDA UDI
Generic Name
Pulse oximeter FDA UDI
Device Name
Fingertips Oximeter FDA UDI
Model / Reference
FPO-6/0739 FDA UDI
Description
Fingertips Oximeter FDA UDI

Identifiers

Primary DI / UDI-DI
00859811007391 FDA UDI
510(k) Number
K153021 FDA UDI
K190869 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Pulse oximeter

NuvoMed by Nuvomed 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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nuvomed Inc

Sources (1)

  • FDA UDI 5bdfd6a1-b86e-4342-b2ec-5b1e8282ceb9 34 fields · synced May 30, 2026