Identity
- Trade Name
- Lullaby LED Phototherapy System EUDAMEDLullaby FDA UDI
- Generic Name
- Overhead infant phototherapy unit FDA UDI
- Device Name
- Lullaby LED Phototherapy System EUDAMEDASSY, LAMP, XPE FDA UDI
- Model / Reference
- 2052663-001 EUDAMEDLED Phototherapy System FDA UDI
- Description
- ASSY, LAMP, XPE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682117401 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00395HY EUDAMED
- Direct Marketing DI
- 00840682117401 EUDAMED
- FDA Product Code
- LBI FDA UDI
- EMDN Code
- Z12080401 PAEDIATRIC PHOTOTHERAPY EQUIPMENT EUDAMED
- GMDN Term
- Overhead infant phototherapy unit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5700 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Overhead infant phototherapy unit
Lullaby by Datex-Ohmeda Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Datex-Ohmeda Inc.
Sources (2)
- FDA UDI a6282a2b-37cb-44f5-9281-275b3086c3b4 35 fields · synced Jul 13, 2026
- EUDAMED c1482ba0-6e94-4636-a108-6ffde2a53a49 61 fields · synced Jul 13, 2026