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Masimo SET

FDA UDI

Class II (US FDA UDI)

by Masimo Corporation

Identity

Trade Name
Masimo SET FDA UDI
Generic Name
Rigid optical ureteroscope FDA UDI
Device Name
uSpO2 Masimo SET Oximetry Cable, NightOne Connector signal extraction pulse oximeter FDA UDI
Model / Reference
4321 FDA UDI
Description
uSpO2 Masimo SET Oximetry Cable, NightOne Connector signal extraction pulse oximeter FDA UDI

Identifiers

Catalog Number
4321 FDA UDI
Primary DI / UDI-DI
00843997012652 FDA UDI
FDA Product Code
DQA FDA UDI
GMDN Term
Rigid optical ureteroscope 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

Category: Rigid optical ureteroscope

Masimo SET by Masimo Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rigid optical ureteroscope.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Masimo Corporation

Sources (1)

  • FDA UDI 0ee8671f-90ee-4867-9878-e60fa82bc891 36 fields · synced May 30, 2026