Pertrach
10 catalogue numbers from 301-D4558, listed by Engineered Medical Systems, LLC, United States, under Tube, Tracheostomy (W/Wo Connector). 1 manufacturer in China is registered for this product code.
1manufacturer
10catalogue numbers in this listing
1510(k) clearance
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 | Engineered Medical Systems, LLC, United States |
|---|---|
| FDA product code | BTO |
| Device type | Tube, Tracheostomy (W/Wo Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5800 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K914743 |
| Record published | 2016-05-27 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Packaging | Pack of 5 |
| Sizes | Lumen/inner diameter 3 to 5.6 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 301-D4558 | Lumen/Inner Diameter 5.0 mm | In distribution |
| 301-D4557 | Lumen/Inner Diameter 4.0 mm | In distribution |
| 301-D4551 | Lumen/Inner Diameter 5.6 mm | In distribution |
| 301-D4550 | Lumen/Inner Diameter 5.6 mm | In distribution |
| 301-D4553 | Lumen/Inner Diameter 3.0 mm | In distribution |
| 301-D4555 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 301-D4554 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 301-D4556 | Lumen/Inner Diameter 4.0 mm | In distribution |
| 301-D4552 | Lumen/Inner Diameter 3.0 mm | In distribution |
| 301-D4559 | Lumen/Inner Diameter 5.0 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)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K062104 | 2007-04-20 |
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.