Identity
- Trade Name
- Curaplex® FDA UDI
- Generic Name
- Nasal oxygen cannula, carbon-dioxide-sampling FDA UDI
- Device Name
- *DO NOT ORDER* Curaplex® EtCO2 Sampling Line, BVM Attachment, Adult and Pediatric, 7ft Tubing FDA UDI
- Model / Reference
- 301-5107BVM FDA UDI
- Description
- *DO NOT ORDER* Curaplex® EtCO2 Sampling Line, BVM Attachment, Adult and Pediatric, 7ft Tubing FDA UDI
Identifiers
- Catalog Number
- 301-5107BVM FDA UDI
- Primary DI / UDI-DI
- 00810094577551 FDA UDI
- 510(k) Number
- K063813 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
A semi-rigid tube with nasal prongs designed for simultaneous oxygen delivery and carbon dioxide monitoring.
Similar devices
Also classified as Nasal oxygen cannula, carbon-dioxide-sampling.
- CO2 Sampling Nasal Cannula — WESTMED, INC. · 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
- AirLife™ — Airlife, Inc. · Class II
Cleared under the same submission
K063813 also covers:
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bound Tree Medical, Llc
Sources (1)
- FDA UDI f4894c47-5a40-41b3-996a-70203f517e12 35 fields · synced Jul 21, 2026