FDA device listing
Pack, hot or cold, reusable
FDA device listing 1878670225 · Garware Fulflex USA Inc.
Key facts
| Proprietary names | Pack, hot or cold, reusable |
|---|---|
| Owner/operator | Garware Fulflex USA Inc. |
| Owner/operator number | 9029354 |
| Product codes | IME |
| Device names | IME - Pack, Hot Or Cold, Reusable |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.5700 |
| Review panels | Physical Medicine |
| Registered establishments | Garware Fulflex USA Inc. (previously AVCOR Health Care Products, Inc.) |
| Establishment registrations | 1649245 |
| FEI numbers | 3000214907 |
| Establishment operations | Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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