Identity
- Trade Name
- neoBLUE LED Phototherapy System FDA UDI
- Generic Name
- Overhead infant phototherapy unit FDA UDI
- Device Name
- The neoBLUE LED Phototherapy System is a floor-standing, mobile phototherapy light that delivers a narrow band of high-intensity blue light via blue light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia.The neoBLUE® Phototherapy System consists of two products – the neoBLUE LED Phototherapy light source (light) and the neoBLUE LED Phototherapy roll stand. FDA UDI
- Model / Reference
- neoBLUE FDA UDI
- Description
- The neoBLUE LED Phototherapy System is a floor-standing, mobile phototherapy light that delivers a narrow band of high-intensity blue light via blue light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia.The neoBLUE® Phototherapy System consists of two products – the neoBLUE LED Phototherapy light source (light) and the neoBLUE LED Phototherapy roll stand. FDA UDI
Identifiers
- Catalog Number
- 001103 FDA UDI
- Primary DI / UDI-DI
- 00382830011594 FDA UDI
- 510(k) Number
- K160305 FDA UDI
- FDA Product Code
- LBI FDA UDI
- GMDN Term
- Overhead infant phototherapy unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Overhead infant phototherapy unit
neoBLUE LED Phototherapy System by Natus Medical Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Natus Medical Incorporated
Sources (1)
- FDA UDI 028f4d27-1b5e-4d2f-916a-64f94acf0439 37 fields · synced Jun 1, 2026