NomoLine

FDA UDI

Class II (US FDA UDI)

by Masimo Corporation

Identity

Trade Name: NomoLine FDA UDI
Generic Name: Patient monitoring system module, multiple-gas FDA UDI
Device Name: NomoLine HH Infant Nasal CO2 Cannula with O2, 4m FDA UDI
Model / Reference: 4933 FDA UDI
Description: NomoLine HH Infant Nasal CO2 Cannula with O2, 4m FDA UDI

Identifiers

Catalog Number: 4933 FDA UDI
Primary DI / UDI-DI: 10843997016701 FDA UDI
510(k) Number: K171121 FDA UDI
FDA Product Code: CCK FDA UDI
GMDN Term: Patient monitoring system module, multiple-gas FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.1400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Patient monitoring system module, multiple-gas

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

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Also classified as Patient monitoring system module, multiple-gas.

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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 1b183742-d176-411a-b458-3cc993f2dcfc 37 fields · synced May 30, 2026