Medline Industries, Inc.
GEL,ULTRASOUND,BOTTLE,8.5-OZ,CLEAR
8manufacturers in China registered for this device type
1catalogue number
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 | Medline Industries, Inc., United States |
|---|---|
| FDA product code | MUI |
| Device type | Media, Coupling, Ultrasound |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1570 |
| 510(k) | K101952 |
| Record published | 2021-02-24 |
| Record revised | 2026-03-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep away from sunlight. Keep dry |
| Packaging | Case of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CTR001305 | 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
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.