Babytherm 8004 System
Catalogue number 2M22370, listed by Drägerwerk AG & Co. KGaA, Germany, under Warmer, Infant Radiant. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Amphenol (Changzhou) Connector Systems Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Drägerwerk AG & Co. KGaA, Germany |
|---|---|
| FDA product code | FMT |
| Device type | Warmer, Infant Radiant |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5130 |
| 510(k) | K971198 |
| Record published | 2015-10-24 |
| Record revised | 2024-08-23 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2024-08-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2M22370 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 37 |
| Fisher & Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 9 |
| AirLife™ | AirLife Finland Oy | 8 |
| Tarry Probes | Tarry Medical Products, Inc. | 5 |
| Argyle | Cardinal Health | 5 |
| Panda | Datex-Ohmeda, Inc. | 4 |
| AccuTemp Probe | Kentec Medical, LLC | 3 |
| Ameritus | Kentec Medical, LLC | 3 |
| AirLife | Carefusion Finland 320 Oy | 3 |
| F&P Neopuff | Fisher & Paykel Healthcare, Ltd. | 2 |
| Sunflower Warmer, Stand AC120V | Atom Medical Corporation | 2 |
| Heating Element 540W-104V | RPI | 2 |
Showing 12 of 39. All products under Warmer, Infant Radiant
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Draeger, Inc. | 510(k) number | 2016-06-22 | Class II | Nonconforming Material/Component | Risk associated with operating the device in skin temperature mode with temperature sensors attached but no patient connected. | 1,599 units | 2016-12-07 |
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.