Isa Or+

FDA UDI

Class II (US FDA UDI)

by Masimo Corporation

Identity

Trade Name: ISA OR+ FDA UDI
Generic Name: Respiration monitor FDA UDI
Device Name: ISA OR+ and Mounting Bracket Kit FDA UDI
Model / Reference: 9685 FDA UDI
Description: ISA OR+ and Mounting Bracket Kit FDA UDI

Identifiers

Primary DI / UDI-DI: 00843997009317 FDA UDI
510(k) Number: K171121 FDA UDI
FDA Product Code: CCK FDA UDI
GMDN Term: Respiration monitor 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

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

FDA UDI

Category: Respiration monitor

Isa Or+ by Masimo Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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MediPines Gas Exchange Monitor — MEDIPINES CORPORATION · Class II
IRMA — MASIMO CORPORATION · Class II
Nomoline ISA CO2 — 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 9d0464ee-0870-4e03-9fa3-377f67122154 36 fields · synced Jun 1, 2026