NomoLine-O LH Adult Nasal CO2 Cannula with O2
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- NomoLine LH Adult Nasal CO2 Cannula with O2, EUDAMEDNomoLine-O LH Adult Nasal CO2 Cannula with O2 FDA UDINomoLine™ LH Adult Nasal CO2 Cannula with O2 FDA UDI
- Generic Name
- Gas-sampling/monitoring respiratory tubing, single-use FDA UDI
- Device Name
- NomoLine Airway Adapter EUDAMED
- Model / Reference
- 3820 EUDAMEDFDA UDI4456 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17350046131252 EUDAMEDFDA UDI17350046132211 FDA UDI
- Basic UDI-DI
- 084399700000Z3T5D04V004ME EUDAMED
- Unit of Use DI
- 07350046131255 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 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 (3)
- FDA UDI de2d76d8-b2cf-4def-bdf4-912ee3a6887e 32 fields · synced Jul 8, 2026
- FDA UDI 93c4a0d3-ab37-43e9-91e4-b7d77cabb40d 32 fields · synced May 30, 2026
- EUDAMED 53dd4880-6464-4f4c-b4c0-3decdcb4d220 61 fields · synced Jul 8, 2026