HYGIENA-TRACH
Device Facts
| Record ID | K911080 |
|---|---|
| Device Name | HYGIENA-TRACH |
| Applicant | Apdyne Medical Co. |
| Product Code | JOH · Anesthesiology |
| Decision Date | May 20, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5800 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.
