Identity
- Trade Name
- Giraffe Blue Spot PT Lite EUDAMEDFDA UDI
- Generic Name
- Overhead infant phototherapy unit FDA UDI
- Device Name
- Giraffe Blue Spot PT Lite EUDAMEDOEM PART, Giraffe Blue Spot PT ENG, IEC FDA UDI
- Model / Reference
- M1231533 EUDAMEDBL2 FDA UDI
- Description
- OEM PART, Giraffe Blue Spot PT ENG, IEC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682116541 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00394HW EUDAMED
- Direct Marketing DI
- 00840682116541 EUDAMED
- 510(k) Number
- K120820 FDA UDI
- 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
- 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
Giraffe Blue Spot PT Lite by Datex-Ohmeda Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Overhead infant phototherapy unit.
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Cleared under the same submission
K120820 also covers:
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 dfc9f01d-9ef1-44fa-9ccc-0ebeffdefb8d 34 fields · synced Jul 8, 2026
- EUDAMED 03f97210-57de-4250-b403-62e592a5d2b3 61 fields · synced Jul 8, 2026