Pilot tube repair kit is used to repair a leaking pilot line of endotracheal and tracheostomy tubes with inside diameters of 0.032 inch (21 gauge) to 0.050 inch (18 gauge). Use of a pilot…
Pilot tube repair kit is used to repair a leaking pilot line of endotracheal and tracheostomy tubes with inside diameters of 0.032 inch (21 gauge) to 0.050 inch (18 gauge). Use of a pilot tube repair kit can delay the replacement of the endotracheal or tracheostomy tube thus reducing trauma to the patient.
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1), Tianjin (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Pilot Tube Repair Kit | Listed by | Instrumentation Industries, Incorporated, United States |
| FDA product code | BSK |
| Device type | Cuff, Tracheal Tube, Inflatable |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5750 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2015-07-31 |
| Record revised | 2018-03-29 (version 2) |
Specifications
Specifications | MRI safety | MR Unsafe |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Packaging | Ziplock bag of 10, ziplock bag of 5 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.