Identity
- Trade Name
- NomoLine FDA UDI
- Generic Name
- Gas-sampling/monitoring respiratory tubing, single-use FDA UDI
- Device Name
- NomoLine-O HH Adult/Pediatric Airway Adapter Set, 4m FDA UDI
- Model / Reference
- 4990 FDA UDI
- Description
- NomoLine-O HH Adult/Pediatric Airway Adapter Set, 4m FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10843997016756 FDA UDI
- 510(k) Number
- K171121 FDA UDI
- FDA Product Code
- CAT FDA UDI
- GMDN Term
- Gas-sampling/monitoring respiratory tubing, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5340 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Gas-sampling/monitoring respiratory tubing, single-use
NomoLine by Masimo Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Masimo Corporation
Sources (1)
- FDA UDI f66d6b79-2698-4c37-899b-8bf24cc71eb3 36 fields · synced May 30, 2026