FDA device listing
Braun Thermoscan,Vicks
FDA device listing 1488769767 · Kaz USA, Inc., A Helen of Troy Company
Key facts
| Proprietary names | Braun Thermoscan,Vicks |
|---|---|
| Owner/operator | Kaz USA, Inc., A Helen of Troy Company |
| Owner/operator number | 1314800 |
| Premarket submissions | K983295 |
| Product codes | FLL |
| Device names | FLL - Continuous Measurement Thermometer |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.2910 |
| Review panels | General Hospital |
| Registered establishments | Helen of Troy Macao Limited, Kaz USA, Inc., A Helen of Troy Company |
| Establishment registrations | 3004871905, 3006169981, 3010405299 |
| FEI numbers | 3004871905, 3006169981, 3010405299 |
| Establishment operations | Foreign Private Label Distributor, Manufacturer, Repackager/Relabeler, Specification Developer |
| 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