FDA device listing
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
FDA device listing 1489938069 · Worldwide Supplies Limited
Key facts
| Owner/operator | Worldwide Supplies Limited |
|---|---|
| Owner/operator number | 10057941 |
| Premarket submissions | K142430 |
| Product codes | CCK, DQA, DRO, DRT, DSK, DXN, FLL, LDD, MKJ |
| Device names | CCK - Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, DQA - Oximeter, DRO - Pacemaker, Cardiac, External Transcutaneous (Non-Invasive), DRT - Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), DSK - Computer, Blood-Pressure, DXN - System, Measurement, Blood-Pressure, Non-Invasive, FLL - Continuous Measurement Thermometer, LDD - Dc-Defibrillator, Low-Energy, (Including Paddles), MKJ - Automated External Defibrillators (Non-Wearable) |
| Device class | Class II, Class III |
| Classification regulations (21 CFR) | 868.1400, 870.1110, 870.1130, 870.2300, 870.2700, 870.5300, 870.5310, 870.5550, 880.2910 |
| Review panels | Anesthesiology, Cardiovascular, General Hospital |
| Registered establishments | WORLDWIDE SUPPLIES LIMITED |
| Establishment registrations | 3014579161 |
| FEI numbers | 3014579161 |
| Establishment operations | Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 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