Nomoline ISA CO2

FDA UDI

Class II (US FDA UDI)

by Masimo Corporation

Identity

Trade Name: Nomoline ISA CO2 FDA UDI
Generic Name: Respiration monitor FDA UDI
Device Name: Nomoline ISA CO2 FDA UDI
Model / Reference: 4198 FDA UDI
Description: Nomoline ISA CO2 FDA UDI

Identifiers

Primary DI / UDI-DI: 00843997014731 FDA UDI
510(k) Number: K171121 FDA UDI
FDA Product Code: MWI FDA UDI
GMDN Term: Respiration monitor FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2300 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Respiration monitor

Nomoline ISA CO2 by Masimo Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Respiration monitor.

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MediPines Gas Exchange Monitor — MEDIPINES CORPORATION · Class II
IRMA — MASIMO CORPORATION · Class II
ISA OR+ — MASIMO CORPORATION · Class II
Nomoline — MASIMO CORPORATION · Class II
NomoLine — MASIMO CORPORATION · Class II

Cleared under the same submission

K171121 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Masimo Corporation

Sources (1)

FDA UDI 98146d38-495c-42e7-9124-8963a181f8de 36 fields · synced May 30, 2026