Sklar®
Jackson IMP Trach W/Adap SS #6
1manufacturer
70catalogue 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 | Sklar Corporation, United States |
|---|---|
| FDA product code | BTO |
| Device type | Tube, Tracheostomy (W/Wo Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5800 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K981891 |
| Record published | 2017-09-13 |
| Record revised | 2020-06-05 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 78-2146 | In distribution | |
| 78-2014 | In distribution | |
| 78-1716 | In distribution | |
| 78-2100 | In distribution | |
| 78-1717 | In distribution | |
| 78-1710 | In distribution | |
| 78-2111 | In distribution | |
| 78-1318 | In distribution | |
| 78-1312 | In distribution | |
| 78-2115 | In distribution | |
| 78-2017 | In distribution | |
| 78-2028 | In distribution | |
| 78-2147 | In distribution | |
| 78-2113 | In distribution | |
| 78-1718 | In distribution | |
| 78-1310 | In distribution | |
| 78-2029 | In distribution | |
| 78-2026 | In distribution | |
| 78-2219 | In distribution | |
| 78-2214 | In distribution | |
| 78-2025 | In distribution | |
| 78-2110 | In distribution | |
| 78-1319 | In distribution | |
| 78-2218 | In distribution | |
| 78-1712 | In distribution | |
| 78-2024 | In distribution | |
| 78-1720 | In distribution | |
| 78-2144 | In distribution | |
| 78-1715 | In distribution | |
| 78-1314 | In distribution | |
| 78-2020 | In distribution | |
| 78-2117 | In distribution | |
| 78-1719 | In distribution | |
| 78-2148 | In distribution | |
| 78-2027 | In distribution | |
| 78-2030 | In distribution | |
| 78-2216 | In distribution | |
| 78-1700 | In distribution | |
| 78-2120 | In distribution | |
| 78-2000 | In distribution | |
| 78-2031 | In distribution | |
| 78-2013 | In distribution | |
| 78-2015 | In distribution | |
| 78-1714 | In distribution | |
| 78-1722 | In distribution | |
| 78-2116 | In distribution | |
| 78-1317 | In distribution | |
| 78-1316 | In distribution | |
| 78-2018 | In distribution | |
| 78-2032 | In distribution | |
| 78-2010 | In distribution | |
| 78-1315 | In distribution | |
| 78-2012 | In distribution | |
| 78-2114 | In distribution | |
| 78-1711 | In distribution | |
| 78-2119 | In distribution | |
| 78-2215 | In distribution | |
| 78-1320 | In distribution | |
| 78-2011 | In distribution | |
| 78-2145 | In distribution | |
| 78-2016 | In distribution | |
| 78-1300 | In distribution | |
| 78-1311 | In distribution | |
| 78-2033 | In distribution | |
| 78-2217 | In distribution | |
| 78-2118 | In distribution | |
| 78-1313 | In distribution | |
| 78-2150 | In distribution | |
| 78-2019 | In distribution | |
| 78-1713 | 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 |
| 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)
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.