Qoustic Wound Therapy System® Ultrasonic Generator AR1000-GEN

GUDID 00853077002220

Ultrasonic Generator, Qoustic Wound Therapy System®, Model AR1000 Series

AROBELLA MEDICAL, LLC

Ultrasonic surgical system generator

• Primary Device ID: 00853077002220
• NIH Device Record Key: 0ff92f74-0fab-4374-9143-4398d68d8667
• Commercial Distribution Discontinuation: 2017-03-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Qoustic Wound Therapy System® Ultrasonic Generator
• Version Model Number: AR1000
• Catalog Number: AR1000-GEN
• Company DUNS: 839978876
• Company Name: AROBELLA MEDICAL, LLC
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 952-288-2810
• Email: lyoshikawa@arobella.com

Device Dimensions

• Depth: 20.625 Inch
• Depth: 20.625 Inch
• Depth: 20.625 Inch
• Depth: 20.625 Inch

Operating and Storage Conditions

• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853077002220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062544

FDA Product Code

• NRB: Wound Cleaner, Ultrasound

Sterilization

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

[00853077002220]

Liquid Chemical

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-24
• Device Publish Date: 2017-03-01

On-Brand Devices [Qoustic Wound Therapy System® Ultrasonic Generator]

• 00853077002237: Ultrasonic Generator, Qoustic Wound Therapy System®, Model AR1000B Series
• 00853077002220: Ultrasonic Generator, Qoustic Wound Therapy System®, Model AR1000 Series