Forsure
101 catalogue numbers from 11260055, listed by Forsure Medical Products LLC., United States, under Tube, Tracheal (W/Wo Connector). 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
101catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (2), Zhejiang (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Hangzhou Jinlin Medical Appliances Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 11 |
| Jiangxi Yikang Medical Instrument Group Co., Ltd. | Nanchang | Jiangxi | Contract manufacturer | 2 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 18 |
| Qingdao Traworks Co., Ltd. | Qingdao | Shandong | Exporter | 7 |
| Tianjin Medis Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Chilecom Medical Devices Co Ltd | Xiangtan | Hunan | Manufacturer | 5 |
Record
| Listed by | Forsure Medical Products LLC., United States |
|---|---|
| FDA product code | BTR |
| Device type | Tube, Tracheal (W/Wo Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5730 |
| Establishment | Repacker / relabeller |
| 510(k) | K042683 |
| Record published | 2018-02-07 |
| Record revised | 2020-06-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: STORE IN DRY CONDITIONS AWAY FROM HEAT AND LIGHT |
| Packaging | Inner box of 10, master case of 100, inner box of 5, master case of 50, master box of 50, inner biox of 10 |
| Sizes | Lumen/inner diameter 2 to 10 mm; length 7 mm; lumen/inner diameter 6 µm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11260055 | PREFORMED NASAL UNCUFFED | In distribution |
| 11290050 | CUFFED | In distribution |
| 11250040 | PREFORMED ORAL CUFFED | In distribution |
| 11250070 | PREFORMED ORAL CUFFED | In distribution |
| 11210090 | 36Fr | In distribution |
| 11210035 | ENDOTRACHEAL TUBE 14Fr CUFFED | In distribution |
| 11260065 | PREFORMED NASAL UNCUFFED | In distribution |
| 11250060 | PREFORMED ORAL CUFFED | In distribution |
| 11200065 | ENDOTRACHEAL TUBE 26Fr UNCUFFED | In distribution |
| 11280070 | In distribution | |
| 11250065 | PREFORMED ORAL CUFFED | In distribution |
| 11270090 | PREFORMED NASAL CUFFED | In distribution |
| 11240030 | PREFORMED ORAL UNCUFFED | In distribution |
| 11290100 | ENDOTRACHEAL TUBE REINFORCED CUFFED | In distribution |
| 11210055 | 22Fr | In distribution |
| 11280040 | UNCUFFED | In distribution |
| 11200035 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 11200020 | 8 Fr | In distribution |
| 11280095 | UNCUFFED | In distribution |
| 11240060 | PREFORMED ORAL UNCUFFED | In distribution |
| 11290025 | CUFFED | In distribution |
| 11270060 | PREFORMED NASAL CUFFED | In distribution |
| 11290065 | CUFFED | In distribution |
| 11200050 | 20Fr | In distribution |
| 11280050 | UNCUFFED | In distribution |
| 11240055 | Lumen/Inner Diameter 5.5 mm | In distribution |
| 11240075 | PREFORMED ORAL UNCUFFED | In distribution |
| 11210075 | 30Fr | In distribution |
| 11290085 | CUFFED | In distribution |
| 11210045 | 18Fr | In distribution |
| 11280090 | UNCUFFED | In distribution |
| 11250055 | Preformed Oral Cuffed | In distribution |
| 11280035 | UNCUFFED | In distribution |
| 11280030 | UNCUFFED | In distribution |
| 11270035 | PREFORMED NASAL CUFFED | In distribution |
| 11210050 | 20 Fr | In distribution |
| 11260080 | PREFORMED NASAL UNCUFFED | In distribution |
| 11260050 | PREFORMED NASAL UNCUFFED | In distribution |
| 11240045 | PREFORMED ORAL UNCUFFED | In distribution |
| 11240040 | PREFORMED ORAL UNCUFFED | In distribution |
| 11260035 | PREFORMED NASAL UNCUFFED | In distribution |
| 11270075 | PREFORMED NASAL CUFFED | In distribution |
| 11210080 | 32 Fr | In distribution |
| 11250050 | Lumen/Inner Diameter 5.0 mm | In distribution |
| 11260075 | PREFORMED NASAL UNCUFFED | In distribution |
| 11270085 | PREFORMED NASAL CUFFED | In distribution |
| 11200055 | 22Fr | In distribution |
| 11270055 | PREFORMED NASAL CUFFED | In distribution |
| 11270070 | PREFORMED NASAL CUFFED | In distribution |
| 11280045 | UNCUFFED | In distribution |
| 11270045 | PREFORMED NASAL CUFFED | In distribution |
| 11210085 | 34Fr | In distribution |
| 11280065 | UNCUFFED | In distribution |
| 11240050 | PREFORMED ORAL UNCUFFED | In distribution |
| 11290080 | CUFFED | In distribution |
| 11200025 | Lumen/Inner Diameter 2.5 mm | In distribution |
| 11280055 | UNCUFFED | In distribution |
| 11200030 | 12Fr | In distribution |
| 11290070 | CUFFED | In distribution |
| 11250090 | PREFORMED ORAL CUFFED | In distribution |
| 11240065 | PREFORMED ORAL UNCUFFED | In distribution |
| 11200060 | ENDOTRACHEAL TUBE 24Fr UNCUFFED | In distribution |
| 11210025 | ENDOTRACHEAL TUBE 10Fr CUFFED | In distribution |
| 11290060 | CUFFED | In distribution |
| 11290095 | In distribution | |
| 11280080 | UNCUFFED | In distribution |
| 11200040 | 16Fr | In distribution |
| 11250095 | PREFORMED ORAL CUFFED | In distribution |
| 11290030 | CUFFED | In distribution |
| 11270080 | PREFORMED NASAL CUFFED | In distribution |
| 11270065 | PREFORMED NASAL CUFFED | In distribution |
| 11290055 | CUFFED | In distribution |
| 11250100 | PREFORMED ORAL CUFFED | In distribution |
| 11250075 | PREFORMED ORAL CUFFED | In distribution |
| 11290090 | CUFFED | In distribution |
| 11210065 | 26Fr | In distribution |
| 11260040 | PREFORMED NASAL UNCUFFED | In distribution |
| 11250085 | PREFORMED ORAL CUFFED | In distribution |
| 11280060 | UNCUFFED | In distribution |
| 11290075 | CUFFED | In distribution |
| 11270050 | PREFORMED NASAL CUFFED | In distribution |
| 11210030 | ENDOTRACHEAL TUBE 12Fr CUFFED | In distribution |
| 11290035 | cuffed | In distribution |
| 11210040 | 16Fr | In distribution |
| 11280075 | UNCUFFED | In distribution |
| 11210060 | 24 Fr | In distribution |
| 11260030 | PREFORMED NASAL CUFFED | In distribution |
| 11240035 | PREFORMED ORAL UNCUFFED | In distribution |
| 11210095 | 38Fr | In distribution |
| 11270030 | PREFORMED NASAL CUFFED | In distribution |
| 11260070 | PREFORMED NASAL UNCUFFED | In distribution |
| 11250080 | PREFORMED ORAL CUFFED | In distribution |
| 11210100 | 40Fr | In distribution |
| 11260045 | PREFORMED NASAL UNCUFFED | In distribution |
| 11260060 | PREFORMED NASAL UNCUFFED | In distribution |
| 11280085 | UNCUFFED | In distribution |
| 11270040 | PREFORMED NASAL CUFFED | In distribution |
| 11240070 | PREFORMED ORAL UNCUFFED | In distribution |
| 11200045 | 18 Fr | In distribution |
| 11290040 | CUFFED | In distribution |
| 11290045 | CUFFED | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rusch | Teleflex Medical LLC | 301 |
| Shiley | Covidien LP | 295 |
| Mallinckrodt | Covidien LP | 258 |
| Hudson RCI | Teleflex Medical LLC | 241 |
| Portex | ICU Medical, Inc | 208 |
| Parker Flex-Tip | Salter Labs | 164 |
| Parker | Salter Labs | 157 |
| Curaplex | Bound Tree Medical, LLC | 149 |
| SourceMark | Sourcemark, LLC. | 148 |
| Montgomery® Safe-T-Tube™ | Boston Medical Products, Inc. | 144 |
| Sunmed | SunMed Group Holdings, LLC | 112 |
| Sheridan | Teleflex Medical LLC | 100 |
Showing 12 of 374. All products under Tube, Tracheal (W/Wo Connector)
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 |
|---|---|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | 510(k) number | 2026-07-31 | Not classified | Process control | The 6Fr suction catheter could not pass through the samples smoothly. | 27200 |
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.