OYI
- Product code
- OYI
- Device name
- Non-Bronchoscopic Bronchoalveolar Lavage Catheter
- Device class
- Class 1
- 21 CFR
- 21 CFR 868.6810
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (last 3 years)
- 1
FDA classification definition
To perform non-bronchoscopic bronchoalveolar lavage (bal) in adult patients undergoing mechanical ventilation.
Official FDA classification page: OYI
Classification and pathway per current FDA publications. Data from openFDA (CC0).