Qoustic Wound Therapy System® Qoustic Key® AR1000-KEY

GUDID 00853077002121

Qoustic Key®, Qoustic Wound Therapy System®, Model AR1000 Series, for systems set as (M) to use Pre-Paid Minutes (PPM)

AROBELLA MEDICAL, LLC

Soft-tissue ultrasonic surgical system

• Primary Device ID: 00853077002121
• NIH Device Record Key: 77d0a7bb-9f33-4aa7-bc3c-3b1b25ed49b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Qoustic Wound Therapy System® Qoustic Key®
• Version Model Number: AR1000B/D
• Catalog Number: AR1000-KEY
• 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: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Depth: 6 Inch
• Depth: 6 Inch
• Depth: 6 Inch
• Depth: 6 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	00853077002121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062544

FDA Product Code

• NRB: Wound Cleaner, Ultrasound

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-08-06
• Device Publish Date: 2017-03-01

Devices Manufactured by AROBELLA MEDICAL, LLC

• 00853077002220 - Qoustic Wound Therapy System® Ultrasonic Generator: 2018-09-24 Ultrasonic Generator, Qoustic Wound Therapy System®, Model AR1000 Series
• 00853077002237 - Qoustic Wound Therapy System® Ultrasonic Generator: 2018-09-24 Ultrasonic Generator, Qoustic Wound Therapy System®, Model AR1000B Series
• 00853077002244 - Qoustic Choice® Wound Therapy System Ultrasonic Generator: 2018-09-24 Ultrasonic Generator, Qoustic Choice® Wound Therapy System, Model AR1000D Series
• 00853077002008 - Qoustic Wound Therapy System®, Model AR1000 Series: 2018-08-06 Qoustic Wound Therapy System®, Model AR1000 Series - ultrasound wound therapy system for wound debridement and management
• 00853077002015 - Qoustic Wound Therapy System® Converter Hand Piece: 2018-08-06 Hand Piece, Converter, Qoustic Wound Therapy System®, Model AR1000 Series
• 00853077002022 - Qoustic Wound Therapy System®, Cart, AR Series, Type 1, Support: 2018-08-06 Support, Cart, AR Series, Type 1, Qoustic Wound Therapy System®, Model AR1000 Series
• 00853077002039 - Qoustic Wound Therapy System®, Cart, AR Series, Type 1, Base: 2018-08-06 Base, Cart, AR Series, Type 1, Qoustic Wound Therapy System®, Model AR1000 Series
• 00853077002060 - Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 1: 2018-08-06 Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 1 + Qoustic Qurette® Shroud, Type P