FDA device listing
Extra Large Size Warming Suit IOB-304,Infant Full Body/Under Body Blanket IOB-025,Infant Under Body Blanket…
FDA device listing 1720998209 · Gentherm Medical LLC
Key facts
| Proprietary names | Extra Large Size Warming Suit IOB-304,Infant Full Body/Under Body Blanket IOB-025,Infant Under Body Blanket IOB-028,Jackson Warming Blanket IOB-024,Large Full Body Blanket IOB-027,Large Half Body Blanket IOB-026,Large Size Warming Suit IOB-303,Lithotomy/Orthopedic Under Body Blanket IOB-029,Medium Size Warming Suit IOB-302,Small Size Warming Suit IOB-301 |
|---|---|
| Owner/operator | Gentherm Medical LLC |
| Owner/operator number | 10042384 |
| Premarket submissions | K190221 |
| Product codes | DWJ |
| Device names | DWJ - System, Thermal Regulating |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.5900 |
| Review panels | Cardiovascular |
| Registered establishments | Jiangmen Dacheng Medical Equipment Co., Ltd. |
| Establishment registrations | 3010168054 |
| FEI numbers | 3010168054 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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