Identity
- Trade Name
- neoBLUE FDA UDI
- Generic Name
- Blanket/pad infant phototherapy unit FDA UDI
- Device Name
- Disposable mattress cover for the neoBLUE Cozy LED Phototherapy System FDA UDI
- Model / Reference
- Cozy Disposable Mattress Cover FDA UDI
- Description
- Disposable mattress cover for the neoBLUE Cozy LED Phototherapy System FDA UDI
Identifiers
- Catalog Number
- 030760 FDA UDI
- Primary DI / UDI-DI
- 00382830005678 FDA UDI
- 510(k) Number
- K051869 FDA UDI
- FDA Product Code
- LBI FDA UDI
- GMDN Term
- Blanket/pad 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 22.0 Inch FDA UDIWidth — 10.41 Inch FDA UDI
Category: Blanket/pad infant phototherapy unit
neoBLUE by Natus Medical Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K051869 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 Incorporated
Sources (1)
- FDA UDI 00b4cb69-a7ad-49c0-9e3b-5db5edb9b13e 37 fields · synced May 30, 2026