Q-Care Rx
Sales Demonstration Sample, Q Care Rx, Q4, Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse
16manufacturers in China registered for this device type
3catalogue numbers in this listing
1recall
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 | Sage Products 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, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-05-08 |
| Record revised | 2022-07-26 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 20 to 25 °C; Special storage condition: Excursion permitted to 15C to 30C. See USP Controlled Room Temperature |
| Packaging | Case of 20, case of 10 |
| Distribution end date | 2018-03-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6904-S | In distribution | |
| 6912-S | In distribution | |
| 9002 | 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 |
| 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 |
| OralKleen | Oralkleen LLC | 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
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 |
|---|---|---|---|---|---|
| 2018-12-05 | Class II | Nonconforming Material/Component | A voluntary recall of a lot (67924) of Independent Care System due to the potential for damaged Sodium Bicarbonate Mouthpaste (cosmetic) tubes. | 39 Cases (50 kits per case) | 2020-06-15 |
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.