Bed, Pediatric Open Hospital
8 catalogue numbers from 4400, listed by Stryker GmbH, Switzerland, under Bed, Pediatric Open Hospital. 8 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (3), Guangdong (2), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Danyang NEW Hope Medical Equipment Co., Ltd. | Danyang | Jiangsu | Manufacturer | 38 |
| Jiangsu Yongfa Medical Equipment Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 33 |
| Foshan ANY Home Care Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 20 |
| Suzhou Number WIN Medical Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 16 |
| Ningbo Kangmailong Medical Apparatus Co., Ltd. | Cixi City, Ningbo | Zhejiang | Contract manufacturer | 10 |
| Hopefull Medical Equipment Co., Ltd. | Xianning | Hubei | Specification developer | 7 |
| QuantMed LifeTech (Shenzhen) Co., Ltd. | Shenzhencity | Guangdong | Manufacturer | 6 |
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | FMS |
| Device type | Bed, Pediatric Open Hospital |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5140 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2022-06-17 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4400 | In distribution | |
| 4400 | In distribution | |
| 4400 | In distribution | |
| 4400 | In distribution | |
| 4400 | In distribution | |
| 8800 | In distribution | |
| 4400 | In distribution | |
| 4400 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tom 2 | L I N E T spol. s r.o. | 15 |
| Pedicraft | Pedicraft, Inc. | 10 |
| Havasu | Stryker GmbH | 2 |
| C2072CL | Novum Medical Products | 2 |
| Mondeal | Mondeal Medical Systems GmbH | 2 |
| E1981CLT | Novum Medical Products | 1 |
| E1983CG | Novum Medical Products | 1 |
| NB-SSxOC | Novum Medical Products | 1 |
| E2083CG | Novum Medical Products | 1 |
| H1955 Homecare Springfield Crib | Hard Manufacturing Co., Inc. | 1 |
| C1972CL | Novum Medical Products | 1 |
| NB-CSX | Novum Medical Products | 1 |
Showing 12 of 103. All products under Bed, Pediatric Open Hospital
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K960012 | 1996-03-25 |
Recalls
2 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 |
|---|---|---|---|---|
| 2026-02-18 | Class II | Under Investigation by firm | Cribs sold in the USA are missing two access door warning labels. | 590 |
| 2021-05-12 | Class II | Under Investigation by firm | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not b | 2 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.