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Universal Silicone Spray
33manufacturers in China registered for this device type
1catalogue number
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (11), Guangdong (7), Zhejiang (6). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Primecare Medical (Huzhou) Co., Ltd. | Hu Zhou | Zhejiang | Contract manufacturer | 9 |
| Nantong Health & Beyond Hygienic Products Inc. | Rugao | Jiangsu | Contract manufacturer | 2 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Yiwu Ori-Power Medtech Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 46 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Xiamen Firstcare IMP. & EXP. Co., Ltd. | Xiamen | Fujian | Exporter | 40 |
| Emsrun Group | Wuxi | Jiangsu | Specification developer | 34 |
| Hangzhou Primecare Medical Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
Showing 12 of 33. All 33 manufacturers in China registered for Lubricant, Patient
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | KMJ |
| Device type | Lubricant, Patient |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6375 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-04-08 |
| Record revised | 2025-09-19 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature up to 50 °C |
| Packaging | Case of 5, box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN928736 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgilube | HR Pharmaceuticals Inc. | 8 |
| HR Lubricating Jelly | HR Pharmaceuticals Inc. | 8 |
| EndoGlide+™ | Jianerkang Medical Co., Ltd. | 8 |
| HCS | Dyad Medical Sourcing, LLC | 7 |
| Cardinal Health | Cardinal Health 200, LLC | 6 |
| Curaplex | Bound Tree Medical, LLC | 6 |
| Aquagel | Parker Laboratories, Inc. | 5 |
| Dukal | Dukal LLC | 5 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 5 |
| EZ Lubricating | HR Pharmaceuticals Inc. | 4 |
| PremierPro | Prestige Ameritech | 4 |
| Medline | Medline Industries, Inc. | 4 |
Showing 12 of 53. All products under Lubricant, Patient
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-02-24 | Not classified | Other | The irrigation trays contain alcohol prep pads which are included in the scope of a recall initiated by Triad Group, due to a potential bacterial contamination. | 95,647 eaches (total for both Catalogue Numbers) | 2012-04-17 |
| 2011-02-24 | Not classified | Other | The irrigation trays contain alcohol prep pads which are included in the scope of a recall initiated by Triad Group, due to a potential bacterial contamination. | see line 1. | 2012-04-17 |
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.