Identity
- Trade Name
- Neoblue FDA UDI
- Generic Name
- Overhead infant phototherapy unit FDA UDI
- Device Name
- Neoblue Arm FDA UDI
- Model / Reference
- 019030 FDA UDI
- Description
- Neoblue Arm FDA UDI
Identifiers
- Catalog Number
- 019030 FDA UDI
- Primary DI / UDI-DI
- 05713315011221 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Overhead infant phototherapy unit
Neoblue by Natus Medical Denmark ApS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- bili-hut™ — Little Sparrows Technologies, Inc. · Class II
- bili-hut™ — Little Sparrows Technologies, Inc. · Class II
Cleared under the same submission
K160745 also covers:
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 Denmark ApS
Sources (1)
- FDA UDI 17205a42-cd97-4fa2-92f4-8d88b7ed6d98 35 fields · synced May 30, 2026