BED PAD,45DAY,6 PACK,BSM-1W-6
Catalogue number 95080, listed by Securitas Healthcare LLC, United States, under Monitor, Bed Patient. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
1catalogue number
19recalls on this code
Who Else Makes It
Concentrated in Guangdong (7), Jiangsu (2), Hebei (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 |
|---|---|---|---|---|
| Chengdu LI REN Electric Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 3 |
| Yuiyn HOO Industrial Limited | Dong Guan | Guangdong | Contract manufacturer | 3 |
| Perth Electronic Plastic Limited Company | Dongguan | Guangdong | Contract manufacturer | 1 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Jiangsu Rooe Medical Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 31 |
| Zhongshan Saxin Electric Heating Technology Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 27 |
| Foshan Fuzikon Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 21 |
| Hebei Healthplus Medical Device Co Ltd | Handan | Hebei | Manufacturer | 18 |
| Fastsound Acoustic Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 6 |
| Shenzhen Giftshine Technology Co Ltd | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Yingkou Henyi Flow Control Inc. | Yingkou | Liaoning | Contract manufacturer | 5 |
| Shenzhen Contin Medical Device Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 3 |
Showing 12 of 14. All 14 manufacturers in China registered for Monitor, Bed Patient
Record
| Listed by | Securitas Healthcare LLC, United States |
|---|---|
| FDA product code | KMI |
| Device type | Monitor, Bed Patient |
| Device class | Class 1 |
| Regulation | 21 CFR 880.2400 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-07-15 |
| Record revised | 2024-02-29 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Pack of 6 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 95080 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Smart Caregiver | Smart Caregiver Corporation | 442 |
| Posey | Posey Products, LLC | 95 |
| Fall Guardian | Smart Caregiver Corporation | 69 |
| DeRoyal | Deroyal Industries, Inc. | 27 |
| Posey | Tidi Products, LLC | 17 |
| Parasol Patient Fall Prevention System | Parasol Medical | 17 |
| Monitor, Bed Patient | Stryker Sustainability Solutions | 13 |
| Medline | Medline Industries, Inc. | 12 |
| McKesson | Mckesson Medical-Surgical Inc. | 11 |
| Parasol Wireless Patient Fall Prevention System | Parasol Medical | 11 |
| Drivemedical | Drive DeVilbiss Healthcare | 10 |
| Monitor, Bed Patient | Sterilmed, Inc. | 10 |
Showing 12 of 251. All products under Monitor, Bed Patient
Recalls
6 of these are 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 |
|---|---|---|---|---|---|
| 2018-10-11 | Class II | Under Investigation by firm | Damaged capacitor on the printed circuit board. | 1101 | 2020-04-10 |
| 2012-05-04 | Class II | Device Design | The monitor may fail to sound an alarm | 176 units | 2013-09-24 |
| 2012-05-04 | Class II | Device Design | The monitor may fail to sound an alarm | 4,148 units | 2013-09-24 |
| 2012-05-04 | Class II | Device Design | The monitor may fail to sound an alarm | 2,754 units | 2013-09-24 |
| 2012-05-04 | Class II | Device Design | The monitor may fail to sound an alarm | 4,749 units | 2013-09-24 |
| 2012-05-04 | Class II | Device Design | The monitor may fail to sound an alarm | 12,111 units | 2013-09-24 |
| 2011-12-13 | Not classified | Component design/selection | Connection between the call cord and the receptacle may not make a correct connection resulting in a continuous or intermittent (false) signal to the nurse call system | 824 units | 2013-09-24 |
| 2011-12-06 | Not classified | Nonconforming Material/Component | Monitor gives false alarms | 592 units | 2013-09-24 |
| 2010-03-26 | Not classified | Component change control | Product might not indicate low battery alarms or exit alarms when powered by a DC power supply. | 36 units | 2011-09-16 |
| 2010-03-26 | Not classified | Component change control | Product might not indicate low battery alarms or exit alarms when powered by a DC power supply. | 84 units | 2011-09-16 |
| 2010-03-26 | Not classified | Component change control | Product might not indicate low battery alarms or exit alarms when powered by a DC power supply. | 45 units | 2011-09-16 |
| 2010-03-26 | Not classified | Component change control | Product might not indicate low battery alarms or exit alarms when powered by a DC power supply. | 22 units | 2011-09-16 |
| 2009-11-25 | Not classified | Process change control | The cord could come loose from the mat potentially causing a short to the internal wiring. | 65,923 mats | 2011-03-31 |
| 2009-11-25 | Not classified | Process change control | The cord could come loose from the mat potentially causing a short to the internal wiring. | 4,195 mats | 2011-03-31 |
| 2009-11-25 | Not classified | Process change control | The cord could come loose from the mat potentially causing a short to the internal wiring. | 19,997 mats | 2011-03-31 |
| 2009-11-25 | Not classified | Process change control | The cord could come loose from the mat potentially causing a short to the internal wiring. | 29,574 mats | 2011-03-31 |
| 2009-11-25 | Not classified | Process change control | The cord could come loose from the mat potentially causing a short to the internal wiring. | 5,999 mats | 2011-03-31 |
| 2009-11-25 | Not classified | Process change control | The cord could come loose from the mat potentially causing a short to the internal wiring. | 79,995 mats | 2011-03-31 |
| 2009-11-25 | Not classified | Process change control | The cord could come loose from the mat potentially causing a short to the internal wiring. | 3,500 mats | 2011-03-31 |
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.