Dual Neonatal Nasal Cannula 7ft O2 Delivery/CO2 Monitoring, Filter, Microstream
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Dual Neonatal Nasal Cannula 7ft O2 Delivery/CO2 Monitoring, Filter, Microstream FDA UDI
- Generic Name
- Nasal oxygen cannula, carbon-dioxide-sampling FDA UDI
- Device Name
- Oxygen Therapy EUDAMEDDual Neonatal Nasal Cannula 7ft O2 Delivery/CO2 Monitoring, Filter, Microstream Type Luer FDA UDI
- Model / Reference
- 032-13-182U EUDAMEDFDA UDI
- Description
- Dual Neonatal Nasal Cannula 7ft O2 Delivery/CO2 Monitoring, Filter, Microstream Type Luer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055788781677 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05055788781677 EUDAMED
- FDA Product Code
- CAT FDA UDICCK FDA UDI
- EMDN Code
- R0301020301 OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES) EUDAMED
- GMDN Term
- Nasal oxygen cannula, carbon-dioxide-sampling FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5340 FDA UDI868.1400 FDA UDI
- Market of Registration
- Northern Ireland 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
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Nasal oxygen cannula, carbon-dioxide-sampling
Dual Neonatal Nasal Cannula 7ft O2 Delivery/CO2 Monitoring, Filter, Microstream by Flexicare Medical Limited — Class I — MDD, FDA UDI — listed in FDA GUDID…
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Also classified as Nasal oxygen cannula, carbon-dioxide-sampling.
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Flexicare Medical Limited
Sources (2)
- FDA UDI 6d428b11-1369-4a51-ab55-f3b6ff2aa8cd 33 fields · synced Oct 9, 2026
- EUDAMED fba1fd97-75cb-476d-889a-4703e7f36b20 61 fields · synced Oct 8, 2026