Pharmaceutical Innovations
Prep Trode Gentle Conductive Electrode Skin Preparation: 4 L Cubitainer with Dispenser
8manufacturers in China registered for this device type
34catalogue numbers in this listing
5recalls on this code
Who Else Makes It
Concentrated in Guangdong (6), Zhejiang (1), Hubei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Top-rank Health Care Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 7 |
| Shenzhen Yuwen E-Commerce Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 19 |
| Guangzhou Xinbo Electronic Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 18 |
| Shenzhen Huayan E-Commerce Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Ever Strong Manufacturing Ltd | Dongguan | Guangdong | Contract manufacturer | 8 |
| Shenzhen Ulike Smart Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 6 |
| Praywise Technology (Dongguan) Co., Ltd. | Dongguan | Guangdong | Manufacturer | 5 |
| Wuhan Greentek PTY Ltd. | Wuhan | Hubei | Manufacturer | 3 |
Record
| Listed by | Pharmaceutical Innovations, Inc., United States |
|---|---|
| FDA product code | GYB |
| Device type | Media, Electroconductive |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1275 |
| Premarket notification | Exempt |
| Record published | 2019-03-29 |
| 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 |
| Packaging | Pack of 12, pack of 24, pack of 18, tube of 12, pack of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Lectron III Chloride 1 Electrode Conductivity Gel | In distribution | |
| AfterTens Care Cream | In distribution | |
| Pre-Tac TENS Conductive Skin Preparation | In distribution | |
| Q.R. Quick Recovery Defibrillator Gel | In distribution | |
| LECTRON II Electrode Conductivity Gel | In distribution | |
| ElectroMist Electrolyte Spray | In distribution | |
| Lectron III Chloride 2 Electrode Conductivity Gel | In distribution | |
| LECTRON II Electrode Conductivity Gel | In distribution | |
| Lectron III Chloride 10 Electrode Conductivity Gel | In distribution | |
| Lectron III Chloride 2 Electrode Conductivity Gel | In distribution | |
| LECTRON II Electrode Conductivity Gel | In distribution | |
| Q. R. Quick Recovery Defibrillator Gel | In distribution | |
| ElectroMist Electrolyte Spray | In distribution | |
| Q.R. Quick Recovery Defibrillator Gel | In distribution | |
| Prep N Stay Anti-Diaphoretic Skin Preparation | In distribution | |
| Lectron III Chloride 10 Electrode Conductivity Gel | In distribution | |
| TAC GEL Electrically Conductive Adhesive | In distribution | |
| Lectron III Chloride 10 Electrode Conductivity Gel | In distribution | |
| Lectron II Electrode Conductivity Gel | In distribution | |
| Pre-Tac TENS Conductive Skin Preparation | In distribution | |
| ElectroMist Electrolyte Spray | In distribution | |
| Q.R. Quick Recovery Defibrillator Gel | In distribution | |
| Special Thin Q.R. | In distribution | |
| Lectron III Chloride 4 Electrode Conductivity Gel | In distribution | |
| Prep Trode Gentle Conductive Electrode Skin Preparation | In distribution | |
| LECTRON II Electrode Conductivity Gel | In distribution | |
| LECTRON II Electrode Conductivity Gel | In distribution | |
| TAC GEL Electrically Conductive Adhesive | In distribution | |
| Prep Trode Gentle Conductive Electrode Skin Preparation | In distribution | |
| AfterTens Care Cream | In distribution | |
| Lectron III Chloride 4 Electrode Conductivity Gel | In distribution | |
| Prep N Stay Anti-Diaphoretic Skin Preparation | In distribution | |
| LECTRON II Electrode Conductivity Gel | In distribution | |
| Lectron III Chloride 1 Electrode Conductivity Gel | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| NuFACE | Nuface | 11 |
| Ten20 Conductive Paste | D. O. Weaver AND Company | 6 |
| Alpha-Stim | Parker Laboratories, Inc. | 4 |
| Auvon | Shenzhen Yuwen E-Commerce Co., Ltd. | 4 |
| Ecogel 300 | Eco-Med Pharmaceutical Inc | 4 |
| Elefix | Nihon Kohden Corp. | 4 |
| Compumedics Quik-Gel | Compumedics Limited | 4 |
| Signaspray | Parker Laboratories, Inc. | 3 |
| Rochester | Rochester Electro Medical, Inc. | 3 |
| Covidien | Cardinal Health | 3 |
| Jmoon | Shenzhen Ulike Smart Electronics Co., Ltd. | 3 |
| Redux | Parker Laboratories, Inc. | 3 |
Showing 12 of 60. All products under Media, Electroconductive
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-06-19 | Class II | Other | Potential for failed stability antimicrobial effectiveness testing. | 8982 | 2020-07-29 |
| 2019-06-19 | Class II | Other | Potential for failed stability antimicrobial effectiveness testing. | 2020-07-29 | |
| 2019-06-19 | Class II | Other | Potential for failed stability antimicrobial effectiveness testing. | 630 | 2020-07-29 |
| 2019-06-19 | Class II | Other | Potential for failed stability antimicrobial effectiveness testing. | 87140 | 2020-07-29 |
| 2019-06-19 | Class II | Other | Potential for failed stability antimicrobial effectiveness testing. | 71653 | 2020-07-29 |
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.