QMS - AQUA CLEANSE

Basic Information

• Brand Name: QMS - AQUA CLEANSE
• Primary DI: 00850014947163
• Version / Model: 01
• Company Name: QUALITY MEDICAL SUPPLY, INC.
• Labeler DUNS: 969138283
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-12
• Public Version: 1
• Public Version Date: 2019-12-20
• Public Version Status: New
• Public Device Record Key: 31237189-2ef5-4428-9913-d6f980930951

Device Description

AQUA CLEANSE COLON IRRIGATION DEVICE

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KPL	Colonic Irrigation System	Gastroenterology, Urology	876.5220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58181	Colonic lavage unit	A mains electricity (AC-powered) device designed for semi-automated irrigation, washing, and evacuation of debris from the colon (e.g., faeces, mucous, old cells) primarily for therapeutic applications (e.g., chronic constipation). It consists of an electromechanical unit that regulates flow from a pressurized water supply (i.e., tap water), and typically contains water heating elements, temperature controls, and an operating display. It is connected to a tube that is placed in the patient's rectum enabling warm water to irrigate the colon; it is not designed for automated removal of waste (i.e., open system). It is intended to be operated by a healthcare provider in a clinical setting.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850014947163	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K150381	000