Alarm Wireless Nurse Call Unit
Catalogue number 2142, listed by Alimed, LLC, United States, under Monitor, Bed Patient. 14 manufacturers in China are registered for this product 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 | Alimed, LLC, United States |
|---|---|
| FDA product code | KMI |
| Device type | Monitor, Bed Patient |
| Device class | Class 1 |
| Regulation | 21 CFR 880.2400 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-01 |
| Record revised | 2024-02-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2142 | 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
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-02-12 | Not classified | Device Design | Alimed became aware of issue via internal receiving inspection activities on 1/20/09. Firm states that subsequent to this observation, Customer Dissatisfaction inquiry #100192 was generated on 1/22/10. A single unit was received back by A | 30 units | 2011-07-25 |
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.