Bioseal Inc.
Nasal Trumpet
52manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (24), Guangdong (12), Jiangsu (8). 8 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 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Hitec Medical Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 17 |
| Tylenol Medical Instruments Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 15 |
| Guangzhou AMK Medical Equipment Co., Ltd. | Guang Zhou | Guangdong | Contract manufacturer | 10 |
| Guangzhou Shengwei Medical Devices Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 8 |
| Xianju Bever Medical Devices Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 3 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
Showing 12 of 52. All 52 manufacturers in China registered for Airway, Nasopharyngeal
Record
| Listed by | Bioseal, United States |
|---|---|
| FDA product code | BTQ |
| Device type | Airway, Nasopharyngeal |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5100 |
| Establishment | Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-10-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Case of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 17814/10 | In distribution | |
| 17812/10 | In distribution | |
| 17813/10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rusch | Teleflex Medical LLC | 77 |
| Curaplex | Bound Tree Medical, LLC | 67 |
| SunMed | SunMed Group Holdings, LLC | 62 |
| Nasopharyngeal airway | Well Lead Medical Co., Ltd. | 40 |
| McKesson | Mckesson Medical-Surgical Inc. | 38 |
| Cardinal Health | Cardinal Health 200, LLC | 26 |
| SourceMark | Sourcemark, LLC. | 25 |
| Medis | Tianjin Medis Medical Device Co., Ltd. | 24 |
| MedSource Airway Devices | Medsource International, LLC | 22 |
| Kenorex | Kentron Healthcare, Inc. | 13 |
| Kentex | Kentron Healthcare, Inc. | 13 |
| Shiley | Covidien LP | 12 |
Showing 12 of 78. All products under Airway, Nasopharyngeal
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.