Identity
- Trade Name
- ETCO2 Nasal Cannula FDA UDI
- Generic Name
- Nasal oxygen cannula, carbon-dioxide-sampling FDA UDI
- Device Name
- A non-sterile, semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to simultaneously deliver oxygen (O2) and allow sampling of exhaled gas for carbon dioxide (CO2) monitoring through separate prongs. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- A non-sterile, semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to simultaneously deliver oxygen (O2) and allow sampling of exhaled gas for carbon dioxide (CO2) monitoring through separate prongs. FDA UDI
Identifiers
- Catalog Number
- DU1090 FDA UDI
- Primary DI / UDI-DI
- 00850014433215 FDA UDI
- FDA Product Code
- CAT FDA UDI
- GMDN Term
- Nasal oxygen cannula, carbon-dioxide-sampling 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 7 Feet FDA UDI
Category: Nasal oxygen cannula, carbon-dioxide-sampling
ETCO2 Nasal Cannula by Distribution Unlimited, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nasal oxygen cannula, carbon-dioxide-sampling.
- CO2 Sampling Nasal Cannula — WESTMED, INC. · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- Dispo-Med CO2 Sampling Line, MLL, W/Filter — DISPO-MED (MALAYSIA) SDN. BHD. · Class II
- Gas Sampling Lines — SALTER LABS · Class II
- Microstream Advance — ORIDION MEDICAL 1987 LTD. · Class II
- Omnistream — ORIDION MEDICAL 1987 LTD. · Class II
- Curaplex — TRI-ANIM HEALTH SERVICES, INC. · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Distribution Unlimited, Llc
Sources (1)
- FDA UDI a840809d-0ecc-41ac-9ba6-fcbf73d2a037 35 fields · synced May 30, 2026