INFANT HEEL WARMER
Device Facts
| Record ID | K950680 |
|---|---|
| Device Name | INFANT HEEL WARMER |
| Applicant | Baxter Healthcare Corp |
| Product Code | IMD · Physical Medicine |
| Decision Date | Aug 23, 1995 |
| Decision | SN |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5710 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.
