Tracoe Mini
Tracheostomy Tube for Neonates, product variation
1manufacturer
110catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Tracoe Medical Gmbh, Germany |
|---|---|
| FDA product code | BTO |
| Device type | Tube, Tracheostomy (W/Wo Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5800 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K893866 |
| Record published | 2015-10-18 |
| Record revised | 2025-05-08 (version 7) |
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 | Special storage condition: Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Sizes | Lumen/inner diameter 2.5 to 6 mm |
| Distribution end date | 2025-03-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| REF 355-5.5 | Lumen/Inner Diameter 5.5 mm | In distribution |
| REF 355-5.5-C65 | Lumen/Inner Diameter 5.5 mm | In distribution |
| REF 355-5.0-C60 | Lumen/Inner Diameter 5.0 mm | In distribution |
| REF 355-4.0-C50 | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 355-3.0 | Lumen/Inner Diameter 3.0 mm | In distribution |
| REF 355-3.0-C47 | Lumen/Inner Diameter 3.0 mm | In distribution |
| REF 355-5.0-C55 | Lumen/Inner Diameter 5.0 mm | In distribution |
| REF 355-3.5-C25 | Lumen/Inner Diameter 3.5 mm | In distribution |
| REF 355-2.5-C26 | Lumen/Inner Diameter 2.5 mm | In distribution |
| REF 355-3.5-C36 | Lumen/Inner Diameter 3.5 mm | In distribution |
| REF 355-6.0-C66 | Lumen/Inner Diameter 6.0 mm | In distribution |
| REF 355-4.5-C36 | Lumen/Inner Diameter 4.5 mm | In distribution |
| REF 355-2.5-C28 | Lumen/Inner Diameter 2.5 mm | In distribution |
| REF 355-3.0-C30 | Lumen/Inner Diameter 3.0 mm | In distribution |
| REF 355-3.0-C44 | Lumen/Inner Diameter 3.0 mm | In distribution |
| REF 355-3.0-C34 | Lumen/Inner Diameter 3.0 mm | In distribution |
| REF 355-3.0-C32 | Lumen/Inner Diameter 3.0 mm | In distribution |
| REF 355-3.5 | Lumen/Inner Diameter 3.5 mm | In distribution |
| REF 355-4.5-C50 | Lumen/Inner Diameter 4.5 mm | In distribution |
| REF 355-3.5-C22 | Lumen/Inner Diameter 3.5 mm | In distribution |
| REF 355-3.5-C38 | Lumen/Inner Diameter 3.5 mm | In distribution |
| REF 355-5.5-C50 | Lumen/Inner Diameter 5.5 mm | In distribution |
| REF 355-5.5-C45 | Lumen/Inner Diameter 5.5 mm | In distribution |
| REF 355-4.0-C55 | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 355-5.0-C70 | Lumen/Inner Diameter 5.0 mm | In distribution |
| REF 355-6.0 | Lumen/Inner Diameter 6.0 mm | In distribution |
| REF 350-3.5 | Lumen/Inner Diameter 3.5 mm | In distribution |
| REF 355-4.0-C30 | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 355-4.0-C40 | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 355-3.5-C45 | Lumen/Inner Diameter 3.5 mm | In distribution |
| REF 355-4.5-C65 | Lumen/Inner Diameter 4.5 mm | In distribution |
| REF 355-6.0-C58 | Lumen/Inner Diameter 6.0 mm | In distribution |
| REF 355-5.5-C75 | Lumen/Inner Diameter 5.5 mm | In distribution |
| REF 350-4.0 | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 355-2.5 | Lumen/Inner Diameter 2.5 mm | In distribution |
| REF 355-2.5-C40 | Lumen/Inner Diameter 2.5 mm | In distribution |
| REF 355-4.5-C40 | Lumen/Inner Diameter 4.5 mm | In distribution |
| REF 355-3.0-C41 | Lumen/Inner Diameter 3.0 mm | In distribution |
| REF 355-3.5-C28 | Lumen/Inner Diameter 3.5 mm | In distribution |
| REF 355-3.0-C50 | Lumen/Inner Diameter 3.0 mm | In distribution |
| REF 355-4.5-C45 | Lumen/Inner Diameter 4.5 mm | In distribution |
| REF 355-3.5-C60 | Lumen/Inner Diameter 3.5 mm | In distribution |
| REF 355-6.0-C54 | Lumen/Inner Diameter 6.0 mm | In distribution |
| REF 355-5.0-C44 | Lumen/Inner Diameter 5.0 mm | In distribution |
| REF 355-3.5-C32 | Lumen/Inner Diameter 3.5 mm | In distribution |
| REF 355-5.0-C65 | Lumen/Inner Diameter 5.0 mm | In distribution |
| REF 355-5.0 | Lumen/Inner Diameter 5.0 mm | In distribution |
| REF 355-6.0-C50 | Lumen/Inner Diameter 6.0 mm | In distribution |
| REF 355-4.0-C52 | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 355-5.5-C60 | Lumen/Inner Diameter 5.5 mm | In distribution |
| REF 355-2.5-C37 | Lumen/Inner Diameter 2.5 mm | In distribution |
| REF 355-3.5-C55 | Lumen/Inner Diameter 3.5 mm | In distribution |
| REF 355-6.0-C80 | Lumen/Inner Diameter 6.0 mm | In distribution |
| REF 355-4.5-C42 | Lumen/Inner Diameter 4.5 mm | In distribution |
| REF 355-3.0-C55 | Lumen/Inner Diameter 3.0 mm | In distribution |
| REF 355-4.0-C36 | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 355-4.5-C58 | Lumen/Inner Diameter 4.5 mm | In distribution |
| REF 355-2.5-C30 | Lumen/Inner Diameter 2.5 mm | In distribution |
| REF 355-3.5-C42 | Lumen/Inner Diameter 3.5 mm | In distribution |
| REF 350-2.5 | Lumen/Inner Diameter 2.5 mm | In distribution |
| REF 355-3.0-C22 | Lumen/Inner Diameter 3.0 mm | In distribution |
| REF 355-4.5-C60 | Lumen/Inner Diameter 4.5 mm | In distribution |
| REF 355-4.5-C56 | Lumen/Inner Diameter 4.5 mm | In distribution |
| REF 355-3.0-C24 | Lumen/Inner Diameter 3.0 mm | In distribution |
| REF 355-3.5-C50 | Lumen/Inner Diameter 3.5 mm | In distribution |
| REF 355-4.5-C39 | Lumen/Inner Diameter 4.5 mm | In distribution |
| REF 355-5.5-C70 | Lumen/Inner Diameter 5.5 mm | In distribution |
| REF 355-4.0-C33 | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 355-2.5-C34 | Lumen/Inner Diameter 2.5 mm | In distribution |
| REF 355-3.0-C28 | Lumen/Inner Diameter 3.0 mm | In distribution |
| REF 355-6.0-C70 | Lumen/Inner Diameter 6.0 mm | In distribution |
| REF 355-4.0-C38 | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 355-4.0-C47 | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 355-3.0-C38 | Lumen/Inner Diameter 3.0 mm | In distribution |
| REF 355-4.0 | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 355-5.0-C75 | Lumen/Inner Diameter 5.0 mm | In distribution |
| REF 355-5.0-C38 | Lumen/Inner Diameter 5.0 mm | In distribution |
| REF 355-3.5-C34 | Lumen/Inner Diameter 3.5 mm | In distribution |
| REF 355-3.5-C30 | Lumen/Inner Diameter 3.5 mm | In distribution |
| REF 355-4.0-C65 | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 355-3.0-C26 | Lumen/Inner Diameter 3.0 mm | In distribution |
| REF 350-3.0 | Lumen/Inner Diameter 3.0 mm | In distribution |
| REF 355-4.0-C60 | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 355-4.5 | Lumen/Inner Diameter 4.5 mm | In distribution |
| REF 355-5.5-C40 | Lumen/Inner Diameter 5.5 mm | In distribution |
| REF 355-4.5-C52 | Lumen/Inner Diameter 4.5 mm | In distribution |
| REF 888-355-6.0-C | Lumen/Inner Diameter 6.0 mm | Withdrawn |
| REF 888-355-3.0 | Lumen/Inner Diameter 3.0 mm | Withdrawn |
| REF 888-355-3.5 | Lumen/Inner Diameter 3.5 mm | Withdrawn |
| REF 888-355-4.5 | Lumen/Inner Diameter 4.5 mm | Withdrawn |
| REF 888-355-4.0 | Lumen/Inner Diameter 4.0 mm | Withdrawn |
| REF 888-355-2.5-C | Lumen/Inner Diameter 2.5 mm | Withdrawn |
| REF 888-350-3.5-C | Lumen/Inner Diameter 3.5 mm | Withdrawn |
| REF 888-355-3.0-C | Lumen/Inner Diameter 3.0 mm | Withdrawn |
| REF 888-350-4.0 | Lumen/Inner Diameter 4.0 mm | Withdrawn |
| REF 888-355-4.0-C | Lumen/Inner Diameter 4.0 mm | Withdrawn |
| REF 888-350-2.5 | Lumen/Inner Diameter 2.5 mm | Withdrawn |
| REF 888-350-4.0-C | Lumen/Inner Diameter 4.0 mm | Withdrawn |
| REF 888-355-6.0 | Lumen/Inner Diameter 6.0 mm | Withdrawn |
| REF 888-355-5.5 | Lumen/Inner Diameter 5.5 mm | Withdrawn |
| REF 888-355-4.5-C | Lumen/Inner Diameter 4.5 mm | Withdrawn |
| REF 888-350-2.5-C | Lumen/Inner Diameter 2.5 mm | Withdrawn |
| REF 888-355-2.5 | Lumen/Inner Diameter 2.5 mm | Withdrawn |
| REF 888-355-3.5-C | Lumen/Inner Diameter 3.5 mm | Withdrawn |
| REF 888-350-3.0 | Lumen/Inner Diameter 3.0 mm | Withdrawn |
| REF 888-350-3.0-C | Lumen/Inner Diameter 3.0 mm | Withdrawn |
| REF 888-355-5.0 | Lumen/Inner Diameter 5.0 mm | Withdrawn |
| REF 888-355-5.0-C | Lumen/Inner Diameter 5.0 mm | Withdrawn |
| REF 888-350-3.5 | Lumen/Inner Diameter 3.5 mm | Withdrawn |
| REF 888-355-5.5-C | Lumen/Inner Diameter 5.5 mm | Withdrawn |
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 |
| 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 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 30 |
Showing 12 of 77. All products under Tube, Tracheostomy (W/Wo Connector)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K051587 | 2005-10-25 |
| K781729 | 1978-10-24 |
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 | Closed |
|---|---|---|---|---|---|---|---|
| Bryan Medical Inc. | 510(k) number | 2013-04-17 | Class I | Labeling Change Control | The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes. | 5 units | 2013-10-29 |
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.