Identity
- Trade Name
- PlumeSafe® X5™ EUDAMEDFDA UDI
- Generic Name
- Surgical plume evacuation system filter FDA UDI
- Device Name
- Non-orthopedic, Active, Smoke Evacuation Unit, PlumeSafe X5 EUDAMEDFilter, 7/8” (22 mm), 3/8” (9.5 mm), 7/8” (22 mm) Ports FDA UDI
- Model / Reference
- PX5-135-22 EUDAMEDFDA UDI
- Description
- Filter, 7/8” (22 mm), 3/8” (9.5 mm), 7/8” (22 mm) Ports FDA UDI
Identifiers
- Catalog Number
- PX5-135-22 FDA UDI
- Primary DI / UDI-DI
- 10653405987994 EUDAMEDFDA UDI
- Basic UDI-DI
- 084585408750DN EUDAMED
- 510(k) Number
- K240127 FDA UDI
- FDA Product Code
- FYD FDA UDI
- EMDN Code
- Z12019004 SURGICAL SMOKE EVACUATION SYSTEMS EUDAMED
- GMDN Term
- Surgical plume evacuation system filter FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.5070 FDA UDI
- Market of Registration
- Belgium 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
PlumeSafe® X5™ by Conmed Corporation — Class I — 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 | 084585408750DN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
- EUDAMED SRN
- US-MF-000012663
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 555fe450-4644-4797-bc36-1b402a4d750a 61 fields · synced May 30, 2026
- FDA UDI 6330d7ad-9fa1-4ff2-8f6c-fd48cca0dbf3 37 fields · synced May 30, 2026