Identity
- Trade Name
- ORI Airways FDA UDI
- Generic Name
- Nasal oxygen cannula, carbon-dioxide-sampling FDA UDI
- Model / Reference
- DM-4000-AF FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860011532736 FDA UDI
- 510(k) Number
- K143127 FDA UDI
- FDA Product Code
- CCK FDA UDI
- GMDN Term
- Nasal oxygen cannula, carbon-dioxide-sampling FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1400 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
Yes
FDA UDI
Category: Nasal oxygen cannula, carbon-dioxide-sampling
ORI Airways by Focal Point Logistics, LLC — Class II — 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
Cleared under the same submission
K143127 also covers:
- Dispo-Med — DISPO-MED (MALAYSIA) SDN. BHD.
- Dispo-Med All purpose Samp.Line with T-Conn.&Filter, MLLTube 7ft W/Filter&Dryer — DISPO-MED (MALAYSIA) SDN. BHD.
- Dispo-Med All purpose Sampling Line with T-Connector & Filter, FLL, Tube 7ft — DISPO-MED (MALAYSIA) SDN. BHD.
- Dispo-Med All purpose Sampling Line with T-Connector & Filter, MLL, Tube 7ft — DISPO-MED (MALAYSIA) SDN. BHD.
- Dispo-Med All purpose Sampling Line with T-Connector&Filter, MLL, Tube 7ft — DISPO-MED (MALAYSIA) SDN. BHD.
- Dispo-Med All purpose Sampling Line with T-Connector, MLL, Tube 10ft — DISPO-MED (MALAYSIA) SDN. BHD.
- Dispo-Med Anaesthetic Gas Sampling Line, MLL, Tube 10FT — DISPO-MED (MALAYSIA) SDN. BHD.
- Dispo-Med Anaesthetic Gas Sampling Line, MLL, Tube 7ft — DISPO-MED (MALAYSIA) SDN. BHD.
- Dispo-Med CO2 Sampling Line w/Filter — DISPO-MED (MALAYSIA) SDN. BHD.
- Dispo-Med CO2 Sampling Line, FLL — DISPO-MED (MALAYSIA) SDN. BHD.
- Dispo-Med CO2 Sampling Line, MLL — DISPO-MED (MALAYSIA) SDN. BHD.
- Dispo-Med CO2 Sampling Line, MLL, W/Filter — DISPO-MED (MALAYSIA) SDN. BHD.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Focal Point Logistics, LLC
Sources (1)
- FDA UDI 591e031e-6b18-4c77-b707-30685c241ead 34 fields · synced May 30, 2026