FDA device listing
HAWK,Safeguard - Advanced Hypothermia Mgt
FDA device listing 1259661079 · Safeguard US Holdco, Inc.
Key facts
| Proprietary names | HAWK,Safeguard - Advanced Hypothermia Mgt |
|---|---|
| Owner/operator | Safeguard US Holdco, Inc. |
| Owner/operator number | 10031323 |
| 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 | SAFEGUARD US OPERATING, LLC |
| Establishment registrations | 3008258694 |
| FEI numbers | 3008258694 |
| Establishment operations | Repackager/Relabeler, Specification Developer |
| 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