Navina™ Smart System

Basic Information

• Brand Name: Navina™ Smart System
• Primary DI: 07333387052625
• Version / Model: 69109
• Catalog Number: 6910940
• Company Name: Wellspect AB
• Labeler DUNS: 351118942
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-10
• Public Version: 1
• Public Version Date: 2025-01-20
• Public Version Status: New
• Public Device Record Key: 4a373761-aae7-49bf-995d-d543b53d13c1

Device Description

Navina Smart Transanal Irrigation. 1 Navina Smart control unit, 1 Water container, 1 Tube set, 1 Accessory set, 1 Navina case. Non Sterile Device. Rx Only.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
KNT	Tubes, gastrointestinal (and accessories)	Gastroenterology, Urology	876.5980	2
FCE	Enema kit	Gastroenterology, Urology	876.5210	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60358	Powered rectal/colostomy irrigation system	A portable assembly of battery-powered devices intended to be used by, or on a patient, for the controlled introduction of a non-medicated solution (typically water) into the rectum to treat faecal incontinence or constipation (rectal irrigation), and/or for colostomy site irrigation; it is not intended for irrigation of the entire colon. It consists of a reservoir, an electronic pump/control unit, connection tubing, and may include patient contact devices (e.g., rectal or colostomy irrigation nozzle/catheter), and a battery charging device (e.g., mains power lead). It is intended for use in the home and healthcare facility. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	07333387052632	GS1		1	In Commercial Distribution
Primary	07333387052625	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a dry place at room temperature.