Shiley
Percutaneous Tracheostomy Tube with Disposable Inner Cannula
1manufacturer
17catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
Record
| Listed by | Covidien LP, United States |
|---|---|
| FDA product code | BTO |
| Device type | Tube, Tracheostomy (W/Wo Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5800 |
| 510(k) | K884730 |
| Record published | 2018-02-06 |
| Record revised | 2025-06-24 (version 13) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature up to 120 °F |
| Packaging | Pack_or_inner_pack of 10, case of 24, pack_or_inner_pack of 2, case of 50, case of 108, case of 10 |
| Sizes | Length 62 to 79 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SSV | In distribution | |
| 8PERC | Length 79 mm | In distribution |
| 6DIC | Length 74 mm | In distribution |
| 4DCP | In distribution | |
| 8DCP | In distribution | |
| 6DCP | In distribution | |
| SSVO | In distribution | |
| 4DIC | Length 62 mm | In distribution |
| SSVO | In distribution | |
| SSV | In distribution | |
| 10DIC | Inner Diameter, 8.9, mm; | In distribution |
| 10DCP | In distribution | |
| SSVO | In distribution | |
| DDCP | In distribution | |
| SSV | In distribution | |
| 6PERC | Length 74 mm | In distribution |
| 8DIC | Length 79 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tracoe® comfort | Tracoe Medical Gmbh | 1,296 |
| Portex | ICU Medical, Inc | 380 |
| Pilling | Teleflex Medical LLC | 248 |
| Premier | Premier Dental Products Co. | 111 |
| Tracoe mini | Tracoe Medical Gmbh | 110 |
| Sklar® | Sklar Corporation | 70 |
| Laryngotec | Andreas Fahl Medizintechnik-Vertrieb GmbH | 66 |
| Blom | Pulmodyne Inc. | 51 |
| Montgomery® Long-Term Cannula | Boston Medical Products, Inc. | 48 |
| Bivona | ICU Medical, Inc | 37 |
| Well Lead Tracheostomy Tube | Well Lead Medical Co., Ltd. | 36 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 36 |
Showing 12 of 77. All products under Tube, Tracheostomy (W/Wo Connector)
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Covidien | 510(k) number | 2026-04-23 | Class II | Labeling Change Control | Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP. | 293,659 devices |
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.