Qoustic Choice® Wound Therapy System, Disposable Tubing Set

Basic Information

• Brand Name: Qoustic Choice® Wound Therapy System, Disposable Tubing Set
• Primary DI: 00853077002183
• Version / Model: AR1000D
• Catalog Number: AR1000D-DTS
• Company Name: AROBELLA MEDICAL, LLC
• Labeler DUNS: 839978876
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-20
• Public Version: 3
• Public Version Date: 2018-08-06
• Public Version Status: Update
• Public Device Record Key: 022fd308-1e93-4183-9332-89150f4f8dd6

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NRB	Wound Cleaner, Ultrasound	General, Plastic Surgery	878.4410	2
LFL	Instrument, Ultrasonic Surgical	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
44778	Soft-tissue ultrasonic surgical system	An assembly of devices that converts high frequency current into ultrasonic oscillation to mechanically fragment soft-tissue cells upon contact with a vibrating tip for cutting and/or coagulating tissue during surgery, possibly in combination with irrigation and aspiration. Ongoing vibration may create heat in cells (diathermy) to increase the cutting/coagulating capacity. It typically includes an energy-producing generator with monitoring functions, a handpiece(s) with tip(s) to convert and apply the energy, connecting cables, a foot-switch as an option to regulate the energy, and possibly an integrated irrigation/suction system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10853077002203	GS1	Case Pallet	12	In Commercial Distribution
Package	00853077002206	GS1	Carton Case	6	In Commercial Distribution
Package	00853077002190	GS1	Carton Box	50	In Commercial Distribution
Primary	00853077002183	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K062544	000
K131096	000

Device Sizes

Type	Value	Unit	Text
Weight	0.1	Pound
Height	0.5	Inch
Width	4.5	Inch
Depth	7.9	Inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity