STERI-VAC(TM) AERATOR MODEL XL
Device Facts
| Record ID | K904921 |
|---|---|
| Device Name | STERI-VAC(TM) AERATOR MODEL XL |
| Applicant | 3M Health Care, Ltd. |
| Product Code | FLI · General Hospital |
| Decision Date | Dec 5, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6100 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An ethyene oxide gas aerator cabinet is a device that is intended for use by a health care provider and consists of a cabinet with a ventilation system designed to circulate and exchange the air in the cabinet to shorten the time required to remove residual ethylene oxide (ETO) from wrapped medical devices that have undergone ETO sterilization. The device may include a heater to warm the circulating air.
