Identity
- Trade Name
- NomoLine FDA UDI
- Generic Name
- Respiration monitor FDA UDI
- Device Name
- NomoLine ISA OR+ LEMO FDA UDI
- Model / Reference
- 4416 FDA UDI
- Description
- NomoLine ISA OR+ LEMO FDA UDI
Identifiers
- Catalog Number
- 4416 FDA UDI
- Primary DI / UDI-DI
- 00843997016902 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Respiration monitor
NomoLine by Masimo Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Respiration monitor.
- IntelliVue CL Respiration Pod — Philips Medizin Systeme Böblingen GmbH · Class II
- Bellavista — VYAIRE MEDICAL, INC. · Class II
- Philips IntelliVue ContactLess Biosensing — Philips Medizin Systeme Böblingen GmbH · Class I
- MediPines Gas Exchange Monitor — MEDIPINES CORPORATION · Class II
- IRMA — MASIMO CORPORATION · Class II
- Nomoline ISA CO2 — MASIMO CORPORATION · Class II
- ISA OR+ — MASIMO CORPORATION · Class II
- Nomoline — MASIMO CORPORATION · Class II
Cleared under the same submission
K171121 also covers:
- ISA OR+ — MASIMO CORPORATION
- NomoLine — MASIMO CORPORATION
- NomoLine — MASIMO CORPORATION
- NomoLine — MASIMO CORPORATION
- NomoLine — MASIMO CORPORATION
- NomoLine — MASIMO CORPORATION
- NomoLine — MASIMO CORPORATION
- NomoLine — MASIMO CORPORATION
- NomoLine-O — MASIMO CORPORATION
- NomoLine-O — MASIMO CORPORATION
- Nomoline — MASIMO CORPORATION
- Nomoline — MASIMO CORPORATION
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 4c15d656-fb97-4372-960f-95508d05e2e7 37 fields · synced Jun 8, 2026