Avanos
BALLARD* Oral Care Mini Swab with Reinforced Plastic Handle
Who Else Makes It
Concentrated in Zhejiang (40), Jiangsu (35), Guangdong (32). 24 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Taizhou Xinkang Medical Materials Co., Ltd. | Taizhou | Jiangsu | Contract manufacturer | 35 |
| Planet (Anhui) Medical Products Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 30 |
| Weihai Kangzheng Medical Equipments Technology Co., Ltd. | Weihai | Shandong | Contract manufacturer | 26 |
| Yiwu Haoding Medical Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 23 |
| Goodwood Medical Care Ltd | Dalian | Liaoning | Contract manufacturer | 19 |
| Hangzhou Aosi Healthcare Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 18 |
| Sino-Vista Dental Instruments Co., Ltd. | Zibo | Shandong | Contract manufacturer | 15 |
Showing 12 of 186. All 186 manufacturers in China registered for Applicator, Absorbent Tipped, Non-Sterile
Record
| Listed by | Avanos Medical, Inc., United States |
|---|---|
| FDA product code | KXF |
| Device type | Applicator, Absorbent Tipped, Non-Sterile |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6025 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-07-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 1000, dsp of 20, case of 25, case of 50, case of 500, case of 16 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 96880 | 250 | In distribution | |
| 96883 | In distribution | ||
| 96873 | 250 | In distribution | |
| 96869 | 250 | In distribution | |
| 12241 | 500 | In distribution | |
| 12249 | In distribution | ||
| 12257 | 20 | In distribution | |
| 12243 | In distribution | ||
| 96881 | 250 | In distribution | |
| 96885 | 144 | In distribution | |
| 12251 | In distribution | ||
| 96886 | 100 | In distribution | |
| 12252 | 500 | In distribution | |
| 12246 | 250 | In distribution | |
| 99946 | In distribution | ||
| 122548 | 250 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Puritan® | Puritan Medical Products Company LLC | 36 |
| JMU | JMU Dental, Inc | 22 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 21 |
| SmartPractice | Smarthealth, Inc. | 21 |
| Cardinal Health | Cardinal Health 200, LLC | 16 |
| Q-Care | Sage Products LLC | 13 |
| Ballard™ | SunMed Group Holdings, LLC | 13 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 10 |
| Alleset | GRI Medical & Electronic Technology Co., Ltd. | 10 |
| Puritan® PurFlock Ultra® | Puritan Medical Products Company LLC | 9 |
| Plasdent | Plasdent Corp. | 9 |
| AMD-Ritmed Solon | AMD Medicom Inc. | 9 |
Showing 12 of 98. All products under Applicator, Absorbent Tipped, Non-Sterile
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 |
|---|---|---|---|---|---|
| 2023-02-03 | Class II | Under Investigation by firm | Incorrect expiration date. | 5,475 cases | 2024-08-19 |
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.