Identity
- Trade Name
- BILI-THERAPY Spot type / Mount Type AC100-240V FDA UDI
- Generic Name
- Overhead infant phototherapy unit FDA UDI
- Model / Reference
- 60377 FDA UDI
Identifiers
- Catalog Number
- 60377 FDA UDI
- Primary DI / UDI-DI
- 04942962603775 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
Dimensions & Sizes
- Size
- Height — 11 Centimeter FDA UDIDepth — 34 Centimeter FDA UDIWidth — 18 Centimeter FDA UDI
Category: Overhead infant phototherapy unit
BILI-THERAPY Spot type / Mount Type AC100-240V by Atom Medical Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Atom Medical Corp
Sources (1)
- FDA UDI 9e43e752-a664-4795-bd11-7676159f89bf 36 fields · synced Jun 1, 2026