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0.5L Hyperinflation System with Pressure Manometer
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref XTF0012Model (R) Emergency Care
Identity
- Trade Name
- 0.5L Hyperinflation System with Pressure Manometer EUDAMEDVenti.Plus FDA UDI
- Generic Name
- Anaesthesia breathing circuit, single-use FDA UDI
- Device Name
- Hyperinflation Kit EUDAMED0.5 HYPERINFLATION W/ MANOMETER FDA UDI
- Model / Reference
- (R) Emergency Care EUDAMEDXTF0012 EUDAMED5405 FDA UDI
- Description
- 0.5 HYPERINFLATION W/ MANOMETER FDA UDI
Identifiers
- Catalog Number
- H050-HD FDA UDI
- Primary DI / UDI-DI
- 04710810100260 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 breathing circuit, single-use 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
No
FDA UDI
0.5L Hyperinflation System with Pressure Manometer by GaleMed Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 b8ab3d1d-94a1-4526-8d4d-6248e0ba3c06 61 fields · synced Jun 20, 2026
- FDA UDI 78620e06-ba38-4358-9374-e88bd9cc13f2 36 fields · synced May 29, 2026