15 Mm Adaptor
Size: 15 Hebeler x 15 mm
9manufacturers in China registered for this device type
6catalogue numbers in this listing
5510(k) clearances naming this product code
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 | Boston Medical Products, Inc., United States |
|---|---|
| FDA product code | BTR |
| Device type | Tube, Tracheal (W/Wo Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5730 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K843936 |
| Record published | 2015-09-20 |
| Record revised | 2022-08-30 (version 4) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep away from sunlight; Special storage condition: Keep dry |
| Packaging | Carton |
| Distribution end date | 2016-04-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 321127 | Fits Size 11-16 mm Montgomery® Safe-T-Tubes™ and 12 mm Hebeler Safe-T-Tubes™ | In distribution |
| 321107 | Fits Size 10 mm Montgomery® Safe-T-Tubes™ | In distribution |
| 321107 | Fits Size 10 mm Montgomery® Safe-T-Tubes™ | In distribution |
| 321127 | Fits Size 11-16 mm Montgomery® Safe-T-Tubes™ and 12 mm Hebeler Safe-T-Tubes™ | In distribution |
| 321157 | Fits Size 15 mm Hebeler Safe-T-Tubes™ | Withdrawn |
| 321187 | Fits Size 18 mm Hebeler Safe-T-Tubes™ | Withdrawn |
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 |
| Forsure | Forsure Medical Products LLC. | 101 |
Showing 12 of 374. All products under Tube, Tracheal (W/Wo Connector)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K960450 | 1996-04-19 |
| K930150 | 1993-02-12 |
| K912290 | 1991-08-26 |
| K903876 | 1991-02-04 |
| K843936 | 1984-12-14 |
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.