Forsure
A sterile hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway. It is typically constructed of…
A sterile hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway. It is typically constructed of plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes to meet the individual needs of the patient. It is typically secured in position by a tracheostomy tube holder fastened around the patient’s neck. This is a single-use device.
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 | Forsure Medical Products LLC., United States |
|---|---|
| FDA product code | BTO |
| Device type | Tube, Tracheostomy (W/Wo Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5800 |
| Establishment | Repacker / relabeller |
| 510(k) | K042684 |
| Record published | 2017-11-16 |
| Record revised | 2020-06-05 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: STORE IN DRY CONDITIONS AWAY FROM HEAT AND LIGHT |
| Packaging | Master case of 100, inner box of 10, inner of 10, master carton of 100 |
| Sizes | Lumen/inner diameter 2 to 10 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11110050 | CUFFED | In distribution |
| 11110075 | CUFFED | In distribution |
| 11100055 | UNCUFFED | In distribution |
| 11110040 | CUFFED | In distribution |
| 11110070 | CUFFED | In distribution |
| 11110085 | CUFFED | In distribution |
| 11100040 | UNCUFFED | In distribution |
| 11110080 | CUFFED | In distribution |
| 11100050 | UNCUFFED | In distribution |
| 11100020 | UNCUFFED | In distribution |
| 11110055 | CUFFED | In distribution |
| 11100025 | UNCUFFED | In distribution |
| 11100045 | UNCUFFED | In distribution |
| 11110060 | In distribution | |
| 11110090 | CUFFED | In distribution |
| 11100035 | UNCUFFED | In distribution |
| 11110045 | CUFFED | In distribution |
| 11100030 | UNCUFFED | In distribution |
| 11110095 | CUFFED | In distribution |
| 11110065 | CUFFED | In distribution |
| 11110100 | CUFFED | 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)
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.