Pure-Vu EVS Waste Bag (Accessory)

Basic Information

• Brand Name: Pure-Vu EVS Waste Bag (Accessory)
• Primary DI: 05060513700199
• Version / Model: PV-WST-03-1
• Catalog Number: PV-WST-03-1
• Company Name: MOTUS GI MEDICAL TECHNOLOGIES LTD
• Labeler DUNS: 532775983
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-06
• Public Version: 1
• Public Version Date: 2023-09-14
• Public Version Status: New
• Public Device Record Key: d2b2b533-ff42-41cc-aaad-bae8f8239daa

Device Description

EVS Waste Bag (Accessory)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12301	Colonic lavage system, powered-flow	A device assembly designed for automated or semi-automated irrigation, washing, and evacuation of debris from the colon. It typically consists of a mains electricity (AC-powered) electromechanical unit that includes a pump for infusion of non-medicated fluids (e.g., saline), an extractor (frequently using vacuum), and controls for the temperature and the rate of infusion (e.g., using a nozzle) and withdrawal of the liquid; the system is coupled to dedicated handpieces and/or to disposable catheters introduced through the rectum. It is intended to be used by a healthcare provider in a clinical setting to remove damaged tissue and/or debris (e.g., faeces, foreign objects).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060513700199	GS1

Customer Contacts

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