Safe-T-Shield Mouthpiece
Mouthpiece, Safety Shield, 2 Piece Scuba Style with Secure-Seal Cover, Disposable
67manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (22), Zhejiang (18), Jiangsu (11). 14 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 |
| Yiwu Ori-Power Medtech Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 46 |
| Hengshui Gangsheng Medical Instruments Co., Ltd. | Hengshui | Hebei | Contract manufacturer | 36 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Shenzhen Senlede Technologies Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 33 |
| Planet (Anhui) Medical Products Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 30 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| IPE Plastic & Hardware Industy, Ltd | Dongguan | Guangdong | Contract manufacturer | 15 |
| Intersurgical Medical Apparatus (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 12 |
| Honsun (Nantong) Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 9 |
| Flying Tooling Engineering Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Ningbo Boya Medical Equipment Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 8 |
Showing 12 of 67. All 67 manufacturers in China registered for Mouthpiece, Breathing
Record
| Listed by | Medi Nuclear Corp., Inc., United States |
|---|---|
| FDA product code | BYP |
| Device type | Mouthpiece, Breathing |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5620 |
| Establishment | Manufacturer |
| Record published | 2017-06-09 |
| Record revised | 2023-07-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Storage | Special storage condition: store at room temperature |
| Packaging | Carton of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MNMP500 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vyaire | Jaeger Medical GmbH | 25 |
| First Aid Only | Acme United Corp. | 15 |
| Micro Medical | Jaeger Medical GmbH | 11 |
| Jaeger | Jaeger Medical GmbH | 9 |
| Clement Clarke International | Clement Clarke Intl., Ltd. | 8 |
| mouthpiece | S D I Diagnostics Inc | 6 |
| Disposable Mouthpiece 35mm OD | Vacumed | 5 |
| Henry Schein | Henry Schein, Inc. | 5 |
| Hudson RCI | Teleflex Medical LLC | 5 |
| MicroMedical | Jaeger Medical GmbH | 5 |
| Micro Medical | Carefusion U.K. 232 Limited | 5 |
| Air Tube | S D I Diagnostics Inc | 4 |
Showing 12 of 188. All products under Mouthpiece, Breathing
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K865093 | 1987-01-15 |
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.