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neoBLUE Compact LED Phototherapy System
FDA UDIFDA 510(k)Class II (US FDA UDI)
510(k) K160305
Identity
- Trade Name
- neoBLUE Compact LED Phototherapy System FDA UDI
- Generic Name
- Overhead infant phototherapy unit FDA UDI
- Device Name
- The neoBLUE compact LED Phototherapy System is a portable phototherapy light that delivers a narrow band of high-intensity blue light via light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia. The neoBLUE® compact LED Phototherapy System can be used in three different configurations: the light source (light) can be used alone, with the neoBLUE compact arm, and with the neoBLUE compact roll stand. FDA UDI
- Model / Reference
- neoBLUE compact FDA UDI
- Description
- The neoBLUE compact LED Phototherapy System is a portable phototherapy light that delivers a narrow band of high-intensity blue light via light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia. The neoBLUE® compact LED Phototherapy System can be used in three different configurations: the light source (light) can be used alone, with the neoBLUE compact arm, and with the neoBLUE compact roll stand. FDA UDI
Identifiers
- Catalog Number
- 018000, 019051, 019001, 019011 FDA UDI
- Primary DI / UDI-DI
- 00382830016773 FDA UDI
- 510(k) Number
- K160745 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 Compact LED Phototherapy System by Natus Medical Incorporated — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Cleared under the same submission
K160745 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160305 | Class II | Active |
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Manufacturer
- Manufacturer
- Natus Medical Incorporated
Sources (2)
- FDA UDI f309ec9b-0981-49c1-9a23-24d44ee79a15 61 fields · synced Jun 18, 2026
- FDA 510(k) K160305 1 fields · synced Jun 5, 2026