FDA device listing
LoFlo CO2 Sampling Cannula with Dehumidification Tubing PEDIATRIC NASAL (3468PEH-00),LoFlo CO2 Sampling O2 Delivery…
FDA device listing 2024180513 · Polimeros Formula de Tecate, SA de CV
Key facts
| Proprietary names | LoFlo CO2 Sampling Cannula with Dehumidification Tubing PEDIATRIC NASAL (3468PEH-00),LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing INFANT/NEONATAL NASAL (3469INH-00),Respironics Novametrix, LLC LoFlo Airway Adapter Kit ADULT/PEDIATRIC (3472ADU-00),Respironics Novametrix, LLC LoFlo Airway Adapter Kit INFANT/NEONATAL (3472INF-00),Respironics Novametrix, LLC LoFlo Airway Adapter… |
|---|---|
| Owner/operator | Polimeros Formula de Tecate, SA de CV |
| Owner/operator number | 10054378 |
| Product codes | CCK |
| Device names | CCK - Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.1400 |
| Review panels | Anesthesiology |
| Registered establishments | Polimeros Formula de Tecate S.A de C.V |
| Establishment registrations | 1000484830 |
| FEI numbers | 1000484830 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database