ACE BRAND INSTANT COLD PACK
Device Facts
| Record ID | K820282 |
|---|---|
| Device Name | ACE BRAND INSTANT COLD PACK |
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| Product Code | IMD · Physical Medicine |
| Decision Date | Feb 12, 1982 |
| Decision | SESE |
| 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.
