Donaldson Ventilation Tubes PT # AG/S9

The Donaldson Ventilation Tubes PT # AG/S9 are explicitly designed for single-use in otolaryngological procedures. This is confirmed by the manufacturer’s description, which states they are supplied sterile and intended for one-time use only, ensuring patient safety and compliance with clinical best practices.

The Donaldson Ventilation Tubes PT # AG/S9 are listed under FDA registration numbers (e.g., 3013557562, 3003678543, etc.) and OpenFDA identifiers, but specific sizing details (e.g., diameter, length) are not provided in the data. However, the product code ETD (Ear, Tympanostomy Device) and the PT # AG/S9 designation imply a standardized design for tympanostomy use. For precise sizing, refer to the manufacturer’s packaging or technical documentation, as these tubes are intended for qualified healthcare professionals to select based on patient needs.

Since the tubes are supplied sterile, they must be stored in their original, sealed packaging to preserve sterility. The data does not specify environmental conditions (e.g., temperature, humidity), but standard medical device storage practices—such as in a clean, dry area away from direct sunlight—are recommended. Always check the manufacturer’s instructions for any additional storage guidelines to ensure integrity before use.

The Donaldson Ventilation Tubes PT # AG/S9 received FDA 510(k) clearance under the Traditional Review pathway, with a decision date of November 14, 1988. The clearance was granted as Substantially Equivalent (SESE) to a predicate device, and the submission was reviewed by the Ear, Nose, and Throat (EN) Advisory Committee. The product is classified as a Class II medical device under product code ETD, indicating it undergoes additional regulatory oversight beyond general controls.