ACU-EVAC

GUDID 10814105020453

Top of the line surgical smoke evacuator. Specifically designed for use with erbium smoke. Also suitable for use with CO2, hair removal, and other laser or electrosurgical units in open procedures or with reducer for handpiece or laparoscopic use. 110vac motor

ACUDERM, INC.

Surgical plume evacuation system

• Primary Device ID: 10814105020453
• NIH Device Record Key: 332e3cf7-87c8-4916-b082-aaf887f12c8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACU-EVAC
• Version Model Number: EVAC II-1
• Company DUNS: 071426803
• Company Name: ACUDERM, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 954-733-6935
• Email: cust-service@acuderm.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10814105020453 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K930043

FDA Product Code

• FYD: Apparatus, Exhaust, Surgical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-13
• Device Publish Date: 2020-01-03

On-Brand Devices [ACU-EVAC]

• 10814105020507: Includes TX Nozzle, preliminary filter, 18" hose section assembly, connects to Hose, Intended fo
• 10814105020491: Includes TX Nozzle, preliminary filter, 8" hose section assembly, connects to Hose, Intended for
• 10814105020460: Top of the line surgical smoke evacuator. Specifically designed for use with erbium smoke. Also
• 10814105020453: Top of the line surgical smoke evacuator. Specifically designed for use with erbium smoke. Also
• 10814105020446: All purpose surgical smoke evacuator. Suitable for use with CO2, erbium, hair removal, and other
• 10814105020439: All purpose surgical smoke evacuator. Suitable for use with CO2, erbium, hair removal, and other
• 10814105020422: Wall Mount starter package includes Acu-Evac II, Wall mount bracket, M-1 main filter, Hose and 5
• 10814105020415: Wall Mount starter package includes Acu-Evac IE, Wall mount bracket, M-1 main filter, Hose and 5
• 10814105020408: Cart mount starter package includes Acu-Evac II unit, Cart, Boom Arm, Foot Switch, M-1 Main Filt
• 10814105020392: Cart mount starter package includes Acu-Evac IE unit, Cart, Boom Arm, Foot Switch, M-1 Main Filt
• 00814105021668: TX NOZZLE STARTER KIT PACK, EVAC HOSE 9"" 5/PER BAG
• 00814105020586: Rubber feet Acu-Evac 1E or Acu-Evac II when mounting on a tabletop or countertop
• 00814105020579: Cart bracket for mounting of a Hyfrecator or other electrosurgical unit to an Evac cart, above t
• 00814105020562: Cart for mounting of Evac unit that provides portability and convenience. Unit has four wheels
• 00814105020555: Wall mount bracket for mounting Acu-Evac IE-1 and Acu-Evac II to a wall
• 00814105020548: Pneumatic foot switch provides convenient ON-OFF control of Acu-Evac
• 00814105020531: Flexible boom arm holds hose and nozzle in place for hands free operation. Not intended for use
• 00814105020524: Hose connector used to connect TX Pack or LTX Pack to hose
• 00814105020517: 6 ft. long x 1.3" diameter hose with connector for use with TX Pack or LTX Pack
• 00814105020487: Consists of a charcoal/odor filter and an ULPA filter-rated 99.9997% efficiency on particles 0..
• 00814105020470: Consists of a charcoal/odor filter and an ULPA filter-rated 99.9997% efficiency on particles 0..