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Venti.Plus Hyperinflation Kit, 0.25L
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AR0023Model (R) Emergency Care
Identity
- Trade Name
- Venti.Plus Hyperinflation Kit, 0.25L EUDAMEDVenti.Plus FDA UDI
- Generic Name
- Anaesthesia face mask, reusable FDA UDI
- Device Name
- Hyperinflation Kit EUDAMED
- Model / Reference
- (R) Emergency Care EUDAMEDAR0023 EUDAMEDH025 FDA UDI
Identifiers
- Catalog Number
- Hyperinflation System 0.25L FDA UDI
- Primary DI / UDI-DI
- 04710810117374 EUDAMEDFDA UDI
- Basic UDI-DI
- 471081008NNRRAE EUDAMED
- 510(k) Number
- K092687 FDA UDI
- FDA Product Code
- NHK FDA UDI
- EMDN Code
- R02010101 BREATHING CIRCUITS, W/O WATER TRAP EUDAMED
- GMDN Term
- Anaesthesia face mask, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5905 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Venti.Plus Hyperinflation Kit, 0.25L by GaleMed Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471081008NNRRAE | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- GaleMed Corporation
- EUDAMED SRN
- TW-MF-000022411
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED dde334f2-6faa-422b-b7c9-6c1eaceca5b8 61 fields · synced Jun 19, 2026
- FDA UDI 6c06dbd8-adb1-4bdf-a9dd-5bda34c00277 34 fields · synced May 30, 2026