Pharmaceutical Innovations
UltraPhonic Conductivity Gel, Aqueous Coupling Agent for Ultrasound and Electromedical Procedures, 4 Liter Cubitainer with Dispenser
8manufacturers in China registered for this device type
27catalogue numbers in this listing
4510(k) clearances naming this product code
3recalls on this code
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 | Pharmaceutical Innovations, Inc., United States |
|---|---|
| FDA product code | MUI |
| Device type | Media, Coupling, Ultrasound |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1570 |
| Premarket notification | Exempt |
| Record published | 2016-09-20 |
| Record revised | 2026-03-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 12, pack of 24, pack of 2, pack of 25, pack of 200 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| UltraPhonic Conductivity Gel | In distribution | ||
| UltraPhonic Scanning Gel | In distribution | ||
| UltraPhonic Conductivity Gel | In distribution | ||
| UltraPhonic Conductivity Gel | In distribution | ||
| UltraPhonic Scanning Gel | In distribution | ||
| Other-Sonic High Viscosity Generic Ultrasound Gel | In distribution | ||
| UltraPhonic FREE Conductivity Gel | In distribution | ||
| GAMMA Massage & Ultrasound Gel | In distribution | ||
| UltraPhonic Conductivity Gel | In distribution | ||
| Other-Sonic High Viscosity Generic Ultrasound Gel | In distribution | ||
| UltraPhonic Focus Thin Gel Pad | 2 | In distribution | |
| UltraPhonic FREE Conductivity Gel | In distribution | ||
| VetGel Veterinary Ultrasound Gel | In distribution | ||
| Other-Sonic High Viscosity Generic Ultrasound Gel | In distribution | ||
| UltraPhonic Conductivity Gel | In distribution | ||
| UltraPhonic Conductivity Gel | In distribution | ||
| GAMMA Massage & Ultrasound Gel | In distribution | ||
| UltraPhonic Focus BP Gel Pad | 2 | In distribution | |
| UltraPhonic Focus Gel Pad | In distribution | ||
| Photon Transmitting Gel | In distribution | ||
| GAMMA Massage & Ultrasound Gel | In distribution | ||
| UltraPhonic Scanning Gel | In distribution | ||
| UltraPhonic Conductivity Gel | In distribution | ||
| UltraPhonic FREE Conductivity Gel | In distribution | ||
| UltraPhonic Focus Gel Pad | In distribution | ||
| Photon Transmitting Gel | In distribution | ||
| UltraPhonic Scanning Gel | 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 |
| 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 |
| Dukal | Dukal LLC | 4 |
Showing 12 of 40. All products under Media, Coupling, Ultrasound
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K163027 | 2018-01-09 |
| K163026 | 2018-01-09 |
| K163023 | 2018-01-08 |
| K163024 | 2018-01-08 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. 1 is recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-08-13 | Class II | No Marketing Application | The firm registered the product as a Class I device, but has since been informed by FDA that the device is not Class I and requires a 510(k) submission. | tbd | 2021-09-16 |
| 2012-03-02 | Not classified | Employee error | Other-Sonic GENERIC ULTRASOUND TRANSMISSION GEL is being recalled due to possible microbial contamination. An FDA Safety Communication was issued for this product on April 18, 2012. | 40,164 units in distribution worldwide – unable to obtain un | 2021-07-19 |
| 2012-03-02 | Not classified | Employee error | Other-Sonic GENERIC ULTRASOUND TRANSMISSION GEL is being recalled due to possible microbial contamination. An FDA Safety Communication was issued for this product on April 18, 2012. | 40,164 units in distribution worldwide – unable to obtain un | 2021-07-19 |
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.