Universal Bite Block, Adult
Adult Endotracheal Tube Bite Block, 50 Units
14manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (4), Guangdong (4), Jiangsu (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Castle Medical Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 67 |
| IPE Plastic & Hardware Industy, Ltd | Dongguan | Guangdong | Contract manufacturer | 15 |
| Suzhou Avon Textile Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 12 |
| Dongguan Vincent Rehab Devices Company Limited | Dongguan | Guangdong | Contract manufacturer | 11 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shandong Zhushi Pharmaceutical Group Co., Ltd. | Heze | Shandong | Contract manufacturer | 65 |
| Ningbo Chibanda IMP &EXP Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 59 |
| Jan Mao Industries Co., Ltd. | Baise | Guangxi | Manufacturer | 29 |
| Lingxian Dongsheng Textile Co., Ltd. | Dezhou | Shandong | Contract manufacturer | 23 |
| Suzhou Shangchuang Technology Service Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 23 |
| Ningbo Huakun Medical Equipment Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 19 |
| Shaoxing Haitech Medical Products Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 13 |
Showing 12 of 14. All 14 manufacturers in China registered for Support, Breathing Tube
Record
| Listed by | B & B Medical Technologies, Inc., United States |
|---|---|
| FDA product code | JAY |
| Device type | Support, Breathing Tube |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5280 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-12-13 |
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, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11160 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| NeoHug® | Neotech Products, LLC | 20 |
| NeoGrip® | Neotech Products, LLC | 11 |
| Support, Breathing Tube | Hans Rudolph, Inc. | 8 |
| Capette™ | SunMed Group Holdings, LLC | 6 |
| Capette | Westmed, Inc. | 6 |
| AincA® | Anesthesia Associates, Inc. | 4 |
| Strapette™ | SunMed Group Holdings, LLC | 4 |
| Septal-H™ | SunMed Group Holdings, LLC | 4 |
| Strapette | Westmed, Inc. | 4 |
| ICU Medical, Inc. | ICU Medical, Inc | 4 |
| CS-ARM | W.T. Farley, Inc. | 4 |
| Support, Breathing Tube | VBM Medizintechnik Gmbh | 4 |
Showing 12 of 63. All products under Support, Breathing Tube
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K873491 | 1987-10-20 |
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.