CASTLE MODEL 3341 & 3441 & 4141 GAS AER
Device Facts
| Record ID | K831595 |
|---|---|
| Device Name | CASTLE MODEL 3341 & 3441 & 4141 GAS AER |
| Applicant | Castle Co. |
| Product Code | FLI · General Hospital |
| Decision Date | Jun 15, 1983 |
| 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.
