SUR-FIT NATURA

Basic Information

• Brand Name: SUR-FIT NATURA
• Primary DI: 00768455104017
• Version / Model: 401913
• Company Name: CONVATEC, PURCHASING DEPARTMENT
• Labeler DUNS: 809784593
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 8
• Public Version Date: 2023-04-25
• Public Version Status: Update
• Public Device Record Key: e05bcc22-88d7-4d68-b853-e08992f54179

Device Description

Visi-Flow® Irrigation Sleeve Transparent 2 1/4"

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	00768455104017	GS1
Unit of Use	00768455157709	GS1
Package	10768455104014	GS1	Case	14	In Commercial Distribution

Customer Contacts

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