Identity
- Trade Name
- ACU-EVAC FDA UDI
- Generic Name
- Surgical plume evacuation system FDA UDI
- Device Name
- Consists of a charcoal/odor filter and an ULPA filter-rated 99.9997% efficiency on particles 0..01 micron and 0.12 microns MPPS. Normal use filter life: 16 hours except for erbium smoke. FDA UDI
- Model / Reference
- M1-FILTER FDA UDI
- Description
- Consists of a charcoal/odor filter and an ULPA filter-rated 99.9997% efficiency on particles 0..01 micron and 0.12 microns MPPS. Normal use filter life: 16 hours except for erbium smoke. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814105020470 FDA UDI
- 510(k) Number
- K930043 FDA UDI
- FDA Product Code
- FYD FDA UDI
- GMDN Term
- Surgical plume evacuation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5070 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Category: Surgical plume evacuation system
Acu-Evac by Acuderm, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- MediSourceNet, Inc — Medisourcenet, Inc · Class II
- MediMax Tech — MEDIMAX TECH INC. · Class II
Cleared under the same submission
K930043 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Acuderm, Inc.
Sources (1)
- FDA UDI ced6d2ed-c5ea-4064-9267-63c030004da7 35 fields · synced Jun 8, 2026