FDA device listing
Infant heel warmer (chemical heat pack)
FDA device listing 1677594692 · INTCO MEDICAL TECHNOLOGY VIET NAM COMPANY LIMITED
Key facts
| Proprietary names | Infant heel warmer (chemical heat pack) |
|---|---|
| Owner/operator | INTCO MEDICAL TECHNOLOGY VIET NAM COMPANY LIMITED |
| Owner/operator number | 10061749 |
| Premarket submissions | K053254 |
| Product codes | MPO |
| Device names | MPO - Infant Heel Warmer (Chemical Heat Pack) |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.5710 |
| Review panels | Physical Medicine |
| Registered establishments | INTCO MEDICAL TECHNOLOGY VIET NAM COMPANY LIMITED |
| Establishment registrations | 3016096058 |
| FEI numbers | 3016096058 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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