Identity
- Trade Name
- Giraffe Shuttle EUDAMEDGiraffe FDA UDI
- Generic Name
- Portable/mobile rechargeable battery pack FDA UDI
- Device Name
- GIRAFFE SHUTTLE EUDAMEDFDA UDI
- Model / Reference
- 2094632-001 EUDAMEDShuttle FDA UDI
- Description
- GIRAFFE SHUTTLE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682110808 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00392HS EUDAMED
- Direct Marketing DI
- 00840682110808 EUDAMED
- FDA Product Code
- FMZ FDA UDIFMT FDA UDI
- EMDN Code
- Z12080499 NEONATOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Portable/mobile rechargeable battery pack FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5400 FDA UDI880.5130 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
Yes
FDA UDI
Category: Portable/mobile rechargeable battery pack
Giraffe 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 Portable/mobile rechargeable battery pack.
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Cleared under the same submission
K101804 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 614e0140-7c8c-4a02-8769-426d96eaa4a9 35 fields · synced Aug 1, 2026
- EUDAMED 6ee33a8a-a982-4ec8-a5ff-7bf7c9088c6a 61 fields · synced Aug 1, 2026