VarioVac D AGA
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- VarioVac D AGA EUDAMEDFDA UDIVarioVac B AGA EUDAMEDFDA UDI
- Generic Name
- General-purpose suction system, pneumatic FDA UDI
- Model / Reference
- MP00510 EUDAMEDFDA UDIMP00504 EUDAMEDFDA UDI208019XK19L020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675029472 EUDAMEDFDA UDI04048675029434 EUDAMEDFDA UDI
- Basic UDI-DI
- 040486751208019XK19L020DY EUDAMED
- Direct Marketing DI
- 04048675029434 EUDAMED04048675029472 EUDAMED
- FDA Product Code
- GCX FDA UDI
- EMDN Code
- A060399 FLUID COLLECTION BAGS AND SYSTEMS - OTHER EUDAMED
- GMDN Term
- General-purpose suction system, pneumatic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6740 FDA UDI
- Market of Registration
- Germany 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
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: General-purpose suction system, pneumatic
VarioVac D AGA by Drägerwerk AG & Co. KGaA — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose suction system, pneumatic.
- Furine Collect — Furine ApS · Class I
- VarioAir D DIN — Drägerwerk AG & Co. KGaA · Class IIa
- Furine plus — Furine ApS · Class I
- VarioAir B/OP Schiene Diss — Drägerwerk AG & Co. KGaA · Class IIa
- Non-sterile aspiration tubes - Flexivac bags — Produtos Médicos Hospitalares, SA · Class I
- Furine — Furine ApS · Class I
- Non-sterile aspiration tubes - Flexivac bags — Produtos Médicos Hospitalares, SA · Class I
- VarioAir B BS — Drägerwerk AG & Co. KGaA · Class IIa
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
- Drägerwerk AG & Co. KGaA
Sources (4)
- FDA UDI 5d9509bd-4454-4d05-bfac-f008e9bf8ff5 33 fields · synced Jul 25, 2026
- FDA UDI b267ea16-e26d-497a-bae4-9b2c54ace739 33 fields · synced May 30, 2026
- EUDAMED d1ac203c-2452-41f4-a841-a89e68538f44 61 fields · synced Jul 11, 2026
- EUDAMED 8fb22272-1764-4a9c-aba3-f66a5342b20b 61 fields · synced Jul 25, 2026