Babyroo TN300 Infant Radiant Warmer
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Babyroo TN300 EUDAMEDBabyroo TN300 Infant Radiant Warmer FDA UDI
- Generic Name
- Infant warmer FDA UDI
- Model / Reference
- MU20300 EUDAMEDFDA UDI306012VK19Z000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049098099042 EUDAMEDFDA UDI
- Basic UDI-DI
- 040486752306012VK19Z000B5 EUDAMED
- Direct Marketing DI
- 04049098099042 EUDAMED
- 510(k) Number
- K230278 FDA 510(k)
- FDA Product Code
- FMT FDA 510(k)FDA UDI
- EMDN Code
- Z12080407 NEONATAL RADIANT WARMERS EUDAMED
- GMDN Term
- Infant warmer FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 880.5130 FDA 510(k)
- Regulation Number
- 880.5130 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The Babyroo TN300 is an Infant Radiant Warmer, designed to provide controlled thermal support for neonates in clinical settings. It employs radiant heat technology to maintain stable body temperature, critical for vulnerable infants during resuscitation, stabilisation, or ongoing care in neonatal units.
This device is configured for open care use, allowing direct access to the infant while maintaining thermoregulation. Supplied as a single-use or reusable system (depending on component configuration), it operates within Class II regulatory classification under FDA and MDR frameworks. The warmer is intended for use in general hospital environments, including delivery rooms and neonatal intensive care units, with no MRI compatibility specified. Storage and handling follow standard medical device protocols as outlined in manufacturer guidelines.
Frequently asked questions
What clinical settings is the Babyroo TN300 Infant Radiant Warmer designed for use in?
The Babyroo TN300 is specifically designed for use in general hospital environments, including delivery rooms and neonatal intensive care units (NICUs). Its open-care configuration allows direct access to the infant while maintaining controlled thermal support, making it ideal for resuscitation, stabilization, or ongoing care of vulnerable neonates.
Can the Babyroo TN300 be reused, or is it intended for single-use only?
The Babyroo TN300 can be supplied as either a single-use or reusable system, depending on the specific component configuration chosen. This flexibility allows facilities to select the option that best fits their operational needs and infection control protocols.
What types of storage and handling guidelines should be followed for the Babyroo TN300?
The Babyroo TN300 follows standard medical device storage and handling protocols as outlined by the manufacturer. While specific details are not provided in the data, it is critical to adhere to these guidelines to ensure proper functionality, sterility (if applicable), and safety during use.
Is the Babyroo TN300 compatible with MRI environments?
The Babyroo TN300 does not specify MRI compatibility in its documentation. Clinicians should assume it is not MRI-safe unless explicitly confirmed by the manufacturer, as radiant warmers typically contain electronic components that could pose risks in MRI environments.
How is the regulatory status of the Babyroo TN300 determined, and what does this mean for buyers?
The Babyroo TN300 is classified under Class II regulatory frameworks for both FDA (510K clearance) and MDR (Medical Device Regulation) in the EU. This classification means it has undergone a premarket review to ensure safety and effectiveness, and buyers can rely on its compliance with these regulatory standards for use in neonatal care settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Dräger Babyroo® TN300, Dräger Babyroo® TN300 | Draeger, PDF THS Neonatal Cart for the Dräger Babyroo TN300 User Manual
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K230278 | Class II | Active |
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Manufacturer
- Manufacturer
- Draeger Medical Systems, Inc.
Sources (3)
- FDA 510(k) K230278 24 fields · synced Oct 6, 2026
- FDA UDI a8453ee7-30fb-49f4-8ed7-289c85f25cac 34 fields · synced May 29, 2026
- EUDAMED 5efaafc3-9c3b-4702-bef9-53953d6fd197 61 fields · synced Jul 16, 2026