Oto-Ease 1/2-Oz Bottles 5/pk
Oto-Ease 1/2-oz bottles 5/pk: 1 catalogue number listed by Westone Laboratories, Inc., United States, under Lubricant, Patient. 33 manufacturers in China are registered for this product 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 | Westone Laboratories, Inc., United States |
|---|---|
| FDA product code | KMJ |
| Device type | Lubricant, Patient |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6375 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-03-02 |
| Record revised | 2024-02-15 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2024-02-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NA | Withdrawn |
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
1 of these is 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 |
|---|---|---|---|---|---|
| 2012-07-13 | Class II | Material/Component Contamination | Westone is recalling all Oto Ease ear lubricant in all packaging configurations and sizes due to potential microbial contamination of the product. | Approx 100k sold annually x 15 years. | 2012-12-14 |
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.