FDA device listing
Infant Transport Mattress Warmer
FDA device listing 1453379089 · Rapid Aid Corp.
Key facts
| Proprietary names | Infant Transport Mattress Warmer |
|---|---|
| Owner/operator | Rapid Aid Corp. |
| Owner/operator number | 10028086 |
| Premarket submissions | K163295 |
| Product codes | IMD |
| Device names | IMD - Pack, Hot Or Cold, Disposable |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.5710 |
| Review panels | Physical Medicine |
| Registered establishments | Danyang Rapid Aid Hot and Cold Therapy Products Co. Ltd, Rapid Aid Corp., RAPID AID CORP., Rapid Aid Vietnam Co., Ltd |
| Establishment registrations | 9710505, 3008955719, 3010039589, 3014982528, 3038103734 |
| FEI numbers | 3003339304, 3008955719, 3010039589, 3014982528, 3038103734 |
| Establishment operations | Complaint File Establishment, Contract Manufacturer, Foreign Private Label Distributor, Manufacturer, 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