Babyroo TN300 Infant Radiant Warmer
Catalogue number MU20300, listed by Draeger Medical Systems, Inc., United States, under Warmer, Infant Radiant. 3 manufacturers in China are registered for this product code.
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 | Draeger Medical Systems, Inc., United States |
|---|---|
| FDA product code | FMT |
| Device type | Warmer, Infant Radiant |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5130 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2023-06-08 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -4 to 140 °F; Storage environment humidity 10 to 95 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MU20300 | In distribution |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243606 | 2025-01-17 |
| K230278 | 2023-05-30 |
| K120642 | 2012-11-02 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2023-05-16 | Class II | Device Design | The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values. | 936 units | |
| 2009-07-29 | Not classified | Process control | Spark, flame and smoke: A mis-positioned crimp on heater element lead wire resulted in flame and smoke aerating from the top of the warmer assembly. | 2915 elements | 2010-10-13 |
| 2009-07-17 | Not classified | Equipment maintenance | Hot particles fell into the infant bassinet beneath a Radiant Infant Warmer. The resulting fire injured an infant. These devices are obsolete. | 6489 units | 2011-06-01 |
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.