FDA device listing
Adult Nasal/Oral CO2 Cannula Capnoflex,Airway Adapter Adult/Pediatric Capnoflex,Airway Adapter Adult/Pediatric Nafion…
FDA device listing 1157723972 · CEVA Logistics Netherlands BV
Key facts
| Proprietary names | Adult Nasal/Oral CO2 Cannula Capnoflex,Airway Adapter Adult/Pediatric Capnoflex,Airway Adapter Adult/Pediatric Nafion Capnoflex,Airway Adapter Pediatric/Infant Nafion Capnoflex,Cannula Nasal CO2 Adult Capnoflex;,Cannula Nasal CO2/O2 Adult Capnoflex;,Cannula Nasal CO2 Only Pediatric Capnoflex,Cannula Oral/Nasal CO2/O2 Adult Capnoflex D,Infant Nasal CO2 Cannula Capnoflex,Infant Nasal CO2/O2… |
|---|---|
| Owner/operator | CEVA Logistics Netherlands BV |
| Owner/operator number | 10086416 |
| Premarket submissions | K083750 |
| Product codes | CCK, DPS, DQA, DQK, DRT, DSB, DSI, DXN, GWQ, MHX |
| Device names | CCK - Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, DPS - Electrocardiograph, DQA - Oximeter, DQK - Computer, Diagnostic, Programmable, DRT - Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), DSB - Plethysmograph, Impedance, DSI - Detector And Alarm, Arrhythmia, DXN - System, Measurement, Blood-Pressure, Non-Invasive, GWQ - Full-Montage Standard Electroencephalograph, MHX - Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.1400, 870.1025, 870.1130, 870.1425, 870.2300, 870.2340, 870.2700, 870.2770, 882.1400 |
| Review panels | Anesthesiology, Cardiovascular, Neurology |
| Registered establishments | CEVA LOGISTICS NETHERLANDS BV (Venray) |
| Establishment registrations | 3018783526 |
| FEI numbers | 3018783526 |
| Establishment operations | Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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