VISI-FLOW NATURA IRRIGATOR W/CONE

Basic Information

• Brand Name: VISI-FLOW NATURA IRRIGATOR W/CONE
• Primary DI: 00768455104253
• Version / Model: 401989
• Company Name: CONVATEC, PURCHASING DEPARTMENT
• Labeler DUNS: 809784593
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 6
• Public Version Date: 2023-05-23
• Public Version Status: Update
• Public Device Record Key: 1b5a1887-7c92-43f6-8507-0e036d7f5f13

Device Description

VISI-FLOW NATURA IRRIGATOR W/CONE US

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
EXD	Irrigator, Ostomy	Gastroenterology, Urology	876.5895	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37716	Colostomy irrigation kit, single-use	A collection of non-sterile devices designed to wash out the colon through a colostomy site. It typically includes a container of fluid, tubing with a cone-shaped tip, or a soft and flexible catheter with a retention shield. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00768455104253	GS1
Package	10768455104250	GS1	Case	1	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K832299	000