Aquasonic 100
Aquasonic 100 Ultrasound Transmission GEL 0.25L
8manufacturers in China registered for this device type
3catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (2), Hong Kong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ming FAI Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| JKH Health Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 22 |
| Jianerkang Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 18 |
| Ming FAI Enterprise International Co., Ltd. | Kowloon | Hong Kong | Exporter | 18 |
| Anhui Deepblue Medical Technology Co., Ltd. | Hefei | Anhui | Contract manufacturer | 16 |
| Hony Medical Co., Ltd. | Taishan | Guangdong | Contract manufacturer | 10 |
| Foshan Pingchuang Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 9 |
| Changzhou Atomic HI-Tech Radiation Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 8 |
Record
| Listed by | Parker Laboratories, Inc., United States |
|---|---|
| FDA product code | MUI |
| Device type | Media, Coupling, Ultrasound |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1570 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-07-05 |
| Record revised | 2018-10-22 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| ULTRASOUND TRANSMISSION GEL | In distribution | ||
| ULTRASOUND TRANSMISSION GEL | 12 | In distribution | |
| ULTRASOUND TRANSMISSION GEL | 200 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Winner EVO Package | Drive DeVilbiss Healthcare | 36 |
| GelShot | Drive DeVilbiss Healthcare | 33 |
| Wavelength | National Therapy Products Inc. | 32 |
| Pharmaceutical Innovations | Pharmaceutical Innovations, Inc. | 27 |
| Therasound EVO Package | Drive DeVilbiss Healthcare | 10 |
| Cardinal Health | Cardinal Health 200, LLC | 7 |
| EcoVue | HR Pharmaceuticals Inc. | 7 |
| HR Ultrasound Jelly | HR Pharmaceuticals Inc. | 7 |
| Medline | Medline Industries, Inc. | 7 |
| Aquasonic Clear | Parker Laboratories, Inc. | 6 |
| Medichoice | Owens & Minor Distribution, Inc. | 5 |
| Aquasonic | Parker Laboratories, Inc. | 5 |
Showing 12 of 40. All products under Media, Coupling, Ultrasound
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K827296 | 1982-04-16 |
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.