Identity
- Trade Name
- HarmonyAIR FDA UDI
- Generic Name
- Surgical plume evacuation system FDA UDI
- Device Name
- The HarmonyAIR Small Shelf 110V Smoke Evacuation System is designed to remove smoke, filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures. FDA UDI
- Model / Reference
- Smoke Evacuation System FDA UDI
- Description
- The HarmonyAIR Small Shelf 110V Smoke Evacuation System is designed to remove smoke, filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures. FDA UDI
Identifiers
- Catalog Number
- QS0018 FDA UDI
- Primary DI / UDI-DI
- 00724995150020 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical plume evacuation system
HarmonyAIR by Steris Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical plume evacuation system.
- MediMax Tech — MEDIMAX TECH INC. · Class II
- Megadyne — Megadyne Medical Products, Inc. · Class II
- Crystal Vision — I.C. Medical, Inc. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- Opaque ULPA Filter & Water Trap — I.C. Medical, Inc. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- ACU-EVAC — ACUDERM, INC. · Class II
- MediSourceNet, Inc — Medisourcenet, Inc · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Steris Corporation
Sources (1)
- FDA UDI 3f342f6a-c70f-48f9-b9df-03878a0be3ea 35 fields · synced Jun 8, 2026