Giraffe Blue Spot PT Lite
FDA UDIEUDAMEDClass II (US FDA UDI)
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, NA FDA UDI
- Model / Reference
- M1224917 EUDAMED2063874-001 EUDAMEDBL1 FDA UDI
- Description
- OEM PART, Giraffe Blue Spot PT, ENG, NA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682116572 EUDAMEDFDA UDI00195278837868 EUDAMED
- Basic UDI-DI
- 8406821BUG00394HW EUDAMED
- Direct Marketing DI
- 00840682116572 EUDAMED00195278837868 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
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
MDR
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 (3)
- FDA UDI 811b9d1c-f5bd-4ddb-873e-169a0ccb1d3f 34 fields · synced Sep 17, 2026
- EUDAMED db93df23-3ea9-4674-a6ad-a77e97085c30 61 fields · synced Jul 17, 2026
- EUDAMED df856c5c-3204-4626-a014-c83ec07774d5 61 fields · synced Sep 17, 2026