Giraffe Stand-alone Infant Resuscitation System
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Giraffe Stand-alone Infant Resuscitation System Bag and Mask EUDAMEDGiraffe Stand-alone Infant Resuscitation System FDA UDI
- Generic Name
- Pulmonary resuscitator, pneumatic, reusable FDA UDI
- Device Name
- Giraffe Stand-alone Infant Resuscitation System EUDAMEDGIRAFFE STAND-ALONE INFANT RESUSCITATION SYSTEM BAG AND MASK FDA UDI
- Model / Reference
- 2082663-002 EUDAMEDBag and Mask FDA UDI
- Description
- GIRAFFE STAND-ALONE INFANT RESUSCITATION SYSTEM BAG AND MASK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682100175 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00396J2 EUDAMED
- Direct Marketing DI
- 00840682100175 EUDAMED
- 510(k) Number
- K070247 FDA UDI
- FDA Product Code
- BTM FDA UDI
- EMDN Code
- Z12080499 NEONATOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Pulmonary resuscitator, pneumatic, reusable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5915 FDA UDI
- Market of Registration
- France EUDAMED
- 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
Yes
Measuring Function
Yes
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
Yes
Category: Pulmonary resuscitator, pneumatic, reusable
Giraffe Stand-alone Infant Resuscitation System 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 Pulmonary resuscitator, pneumatic, reusable.
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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 (2)
- FDA UDI 811fb85e-b5e4-467e-8f49-a36cd870b2fc 35 fields · synced Jul 13, 2026
- EUDAMED 28338226-ef5c-4578-9892-378f2a485957 61 fields · synced Jul 13, 2026