OralKleen
Oral Hygiene Kit
16manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (5), Hebei (3), Shanghai (3).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| Hubei Qianjiang Kingphar Medical Material Co., Ltd. | Qianjiang | Hubei | Contract manufacturer | 52 |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | Cangzhou | Hebei | Manufacturer | 40 |
| Shanghai Alwings Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 39 |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | Yang Jiao Lang Zin’An Town | Zhejiang | Manufacturer | 39 |
| Tiger Medical Group | Shanghai | Shanghai | Specification developer | 38 |
| Henan Baistra Medical Devices Limited | Zhengzhou | Henan | Manufacturer | 34 |
| Hangzhou Wise Medical Device Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 25 |
| Ningbo Cooskin Stationery Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 18 |
Showing 12 of 16. All 16 manufacturers in China registered for Patient Personal Hygiene Kit
Record
| Listed by | Oralkleen LLC, United States |
|---|---|
| FDA product code | NSB |
| Device type | Patient Personal Hygiene Kit |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6855 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-11-15 |
| Record revised | 2024-09-13 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | expiry date |
| Packaging | Case of 20 |
| Distribution end date | 2024-09-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V1.1 | In distribution | |
| V1 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medical Action Industries | Medical Action Industries, Inc. | 63 |
| LSL Healthcare | Lsl Industries, Inc. | 11 |
| Q-Care | Sage Products LLC | 10 |
| Ballard™ | SunMed Group Holdings, LLC | 7 |
| Toothette Oral Care | Sage Products LLC | 4 |
| Ballard* 24-Hour Oral Care Kit | Avanos Medical, Inc. | 4 |
| Q-Care Rx | Sage Products LLC | 3 |
| Avid Trucustom | Medical Action Industries, Inc. | 2 |
| MediChoice | Owens & Minor Distribution, Inc. | 2 |
| Ballard* Assisted Care 24-Hour Oral Care Kit | Avanos Medical, Inc. | 2 |
| AVIDTruCustom | Medical Action Industries, Inc. | 1 |
| Sage Self Oral Care | Sage Products LLC | 1 |
Showing 12 of 15. All products under Patient Personal Hygiene Kit
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.