NomoLine-O LH Adult Nasal/Oral CO2 Cannula with O2
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- NomoLine-O LH Adult Nasal/Oral CO2 Cannula with O2 EUDAMEDFDA UDI
- Generic Name
- Gas-sampling/monitoring respiratory tubing, single-use FDA UDI
- Device Name
- NomoLine-O Nasal, Nasal/Oral Cannulas EUDAMED
- Model / Reference
- 4459 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 17350046132242 EUDAMEDFDA UDI
- Basic UDI-DI
- 084399700000Z3T5D05V002MM EUDAMED
- Unit of Use DI
- 07350046132245 EUDAMED
- FDA Product Code
- CCK FDA UDICAT FDA UDIBZA FDA UDIBYH FDA UDI
- EMDN Code
- R020108 RESPIRATORY GAS MONITORING AND SAMPLING CIRCUITS AND KITS EUDAMED
- GMDN Term
- Gas-sampling/monitoring respiratory tubing, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1400 FDA UDI868.5340 FDA UDI868.5810 FDA UDI868.5995 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Gas-sampling/monitoring respiratory tubing, single-use
NomoLine-O LH Adult Nasal/Oral CO2 Cannula with O2 by Masimo Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Masimo Corporation
Sources (2)
- FDA UDI 8e00b818-4b2f-4f4f-a022-3960bf2afa38 32 fields · synced Oct 7, 2026
- EUDAMED e08b9712-76a5-418e-baf6-f87c9641ab78 61 fields · synced Oct 7, 2026