WatchCare
Hospital Bed Accessory, Watch Care System for VersaCare Bed Rev. A-J
4manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (3), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Providence Enterprise Limited | Shenzhen | Guangdong | Contract manufacturer | 9 |
| Shantou City KIN Seng Plastic Co., Ltd. | Guangdong | Guangdong | Contract manufacturer | 3 |
| Foshan RM Products Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 1 |
| Rosti Integrated Manufacturing Solutions (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 2 |
Record
| Listed by | Hill-ROM, Inc., United States |
|---|---|
| FDA product code | KPN |
| Device type | Alarm, Conditioned Response Enuresis |
| Device class | Class 2 |
| Regulation | 21 CFR 876.2040 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-12-06 |
| Record revised | 2024-09-13 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2024-03-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P00697902 | Withdrawn | |
| P00697903 | Withdrawn | |
| P00697905 | Withdrawn | |
| P00697901 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pjama | Pjama AB | 32 |
| Malem | Malem Medical Ltd | 22 |
| Chummie | Theos Medical Systems, Inc. | 15 |
| Tena | Essity Hygiene and Health AB | 11 |
| Shield | Theos Medical Systems, Inc. | 4 |
| SIM™ tablet accessories | Simavita (Aust) PTY Ltd | 4 |
| SIM™ kit | Simavita (Aust) PTY Ltd | 4 |
| SIM pod kit | Simavita (Aust) PTY Ltd | 4 |
| DryEasy | Marvelworks Ltd. | 2 |
| Kateway | Kateway Limited | 2 |
| Fitright | Medline Industries, Inc. | 2 |
| Smart | Theos Medical Systems, Inc. | 2 |
Showing 12 of 49. All products under Alarm, Conditioned Response Enuresis
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Baxter Healthcare Corporation | UDI-DI | 2022-09-30 | Class I | Device Design | Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps). | 1137 units |
| Baxter Healthcare Corporation | UDI-DI | 2022-09-30 | Class I | Device Design | Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps). | 129 units |
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.