Identity
- Trade Name
- neoBLUE FDA UDI
- Generic Name
- Blanket/pad infant phototherapy unit FDA UDI
- Device Name
- neoBLUE blanket Large Disposable Mattress Cover FDA UDI
- Model / Reference
- Blanket Disposable Mattress Cover Large FDA UDI
- Description
- neoBLUE blanket Large Disposable Mattress Cover FDA UDI
Identifiers
- Catalog Number
- 005989 FDA UDI
- Primary DI / UDI-DI
- 00382830015516 FDA UDI
- 510(k) Number
- K103589 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 — 19.85 Inch FDA UDIWidth — 10.53 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
K103589 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Natus Medical Incorporated
Sources (1)
- FDA UDI e2e535e1-98ff-4bdd-beb0-c7a57f88aba0 37 fields · synced May 30, 2026