Qoustic Choice® Wound Therapy System, Disposable Tubing Set AR1000D-DTS

GUDID 10853077002203

Disposable Tubing Set, Qoustic Choice® Wound Therapy System, Model AR1000D Series

AROBELLA MEDICAL, LLC

Soft-tissue ultrasonic surgical system

• Primary Device ID: 10853077002203
• NIH Device Record Key: 022fd308-1e93-4183-9332-89150f4f8dd6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Qoustic Choice® Wound Therapy System, Disposable Tubing Set
• Version Model Number: AR1000D
• Catalog Number: AR1000D-DTS
• 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: false
• 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: 7.9 Inch
• Depth: 7.9 Inch
• Depth: 7.9 Inch
• Depth: 7.9 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	00853077002183 [Primary]
GS1	00853077002190 [Package]; Contains: 00853077002183; Package: Carton Box [50 Units]; In Commercial Distribution
GS1	00853077002206 [Package]; Contains: 00853077002190; Package: Carton Case [6 Units]; In Commercial Distribution
GS1	10853077002203 [Package]; Contains: 00853077002206; Package: Case Pallet [12 Units]; In Commercial Distribution

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: true

[10853077002203]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-08-06
• Device Publish Date: 2017-01-20

Devices Manufactured by AROBELLA MEDICAL, LLC

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• 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