Identity
- Trade Name
- BiliCocoon™ Service Kit FDA UDI
- Generic Name
- Blanket/pad infant phototherapy unit FDA UDI
- Model / Reference
- BCC010-SK10 FDA UDI
Identifiers
- Catalog Number
- BCC010-SK10 FDA UDI
- Primary DI / UDI-DI
- 03760012570119 FDA UDI
- 510(k) Number
- K163526 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Blanket/pad infant phototherapy unit
BiliCocoon™ Service Kit by Neomedlight — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- neoBLUE — Natus Medical Incorporated · Class II
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
- Neomedlight
Sources (1)
- FDA UDI 6621a17f-eb33-482d-a33c-edc7c4920194 35 fields · synced May 30, 2026