VarioVac MRI P rail
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- VarioVac MRI P Schniene EUDAMEDVarioVac MRI P rail FDA UDI
- Generic Name
- Vacuum suction regulator/regulation set, general-purpose FDA UDI
- Model / Reference
- MP03223 EUDAMEDFDA UDI208019XK19L020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675538011 EUDAMEDFDA UDI
- Basic UDI-DI
- 040486751208019XK19L020DY EUDAMED
- Direct Marketing DI
- 04048675538011 EUDAMED
- FDA Product Code
- GCX FDA UDI
- EMDN Code
- A060399 FLUID COLLECTION BAGS AND SYSTEMS - OTHER EUDAMED
- GMDN Term
- Vacuum suction regulator/regulation set, general-purpose 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: Vacuum suction regulator/regulation set, general-purpose
VarioVac MRI P rail by Drägerwerk AG & Co. KGaA — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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
- Drägerwerk AG & Co. KGaA
Sources (2)
- FDA UDI 4a90b7b9-d975-4f58-a84d-6c141627edba 32 fields · synced Jul 9, 2026
- EUDAMED 72689677-11d7-4046-ba71-3590c82fb8a6 61 fields · synced Jul 9, 2026