ACU-EVAC

GUDID 00814105020562

Cart for mounting of Evac unit that provides portability and convenience. Unit has four wheels two of which swivel

ACUDERM, INC.

Surgical plume evacuation system

• Primary Device ID: 00814105020562
• NIH Device Record Key: 89104270-3ec6-481d-b775-52837aaad2c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACU-EVAC
• Version Model Number: DUALCART
• 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: true
• Serial Number: false
• 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	00814105020562 [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..