Well Lead Tracheostomy Tube
TRACHEOSTOMY TUBES (Uncuffed)I.D. 10.5
1manufacturer
36catalogue 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 | Well Lead Medical Co., Ltd., China |
|---|---|
| FDA product code | BTO |
| Device type | Tube, Tracheostomy (W/Wo Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5800 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer, Exporter |
| 510(k) | K042684 |
| Record published | 2024-03-21 |
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, expiry date, manufacturing date |
| Packaging | Box of 10, carton of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A02A017010 | In distribution | |
| A02A019010 | In distribution | |
| A02A044530 | In distribution | |
| A02A028530 | In distribution | |
| A02A043530 | In distribution | |
| A02A036010 | In distribution | |
| A02A033010 | In distribution | |
| A02A029530 | In distribution | |
| A02A018010 | In distribution | |
| A02A019710 | In distribution | |
| A02A045030 | In distribution | |
| A02A029030 | In distribution | |
| A02A027530 | In distribution | |
| A02A029730 | In distribution | |
| A02A029830 | In distribution | |
| A02A026530 | In distribution | |
| A02A017510 | In distribution | |
| A02A042530 | In distribution | |
| A02A019510 | In distribution | |
| A02A046030 | In distribution | |
| A02A029630 | In distribution | |
| A02A035510 | In distribution | |
| A02A019610 | In distribution | |
| A02A028030 | In distribution | |
| A02A042030 | In distribution | |
| A02A027030 | In distribution | |
| A02A044030 | In distribution | |
| A02A045530 | In distribution | |
| A02A034510 | In distribution | |
| A02A043030 | In distribution | |
| A02A019810 | In distribution | |
| A02A035010 | In distribution | |
| A02A016510 | In distribution | |
| A02A034010 | In distribution | |
| A02A018510 | In distribution | |
| A02A033510 | In distribution |
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| 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 |
| 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.