Identity
- Trade Name
- No EUDAMEDVADI MEDICAL FDA UDI
- Generic Name
- Ventilator breathing circuit, reusable FDA UDI
- Device Name
- Ventilator Tubing / Adult Breathing Tubing EUDAMEDVentilator Tubing Description: Adult Breathing Tubing FDA UDI
- Model / Reference
- G-328000 EUDAMEDFDA UDIG-328000-NP1 EUDAMED
- Description
- Ventilator Tubing Description: Adult Breathing Tubing FDA UDI
Identifiers
- Catalog Number
- G-328000-NP1 FDA UDI
- Primary DI / UDI-DI
- 04719894380841 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04719894380841 EUDAMED
- FDA Product Code
- BZO FDA UDI
- EMDN Code
- R02010199 STANDARD BREATHING CIRCUITS - OTHER EUDAMED
- GMDN Term
- Ventilator breathing circuit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5975 FDA UDI
- Market of Registration
- Germany 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
No by VADI Medical Technology Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04719894380841 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- VADI Medical Technology Co., Ltd.
- EUDAMED SRN
- TW-MF-000022930
- Authorised Representative
- MedNet EC-REP IIb GmbH DE-AR-000011192
Sources (2)
- EUDAMED 1e8c6e32-a4bd-403a-8158-443be32bd67b 61 fields · synced Jul 14, 2026
- FDA UDI c29f9e99-a697-4001-8d18-716f7f834d55 34 fields · synced May 30, 2026