Navina™ Consumable Set Regular

Basic Information

• Brand Name: Navina™ Consumable Set Regular
• Primary DI: 07333387025292
• Version / Model: 69003
• Catalog Number: 6900340
• Company Name: Wellspect AB
• Labeler DUNS: 351118942
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-21
• Public Version: 2
• Public Version Date: 2023-10-02
• Public Version Status: Update
• Public Device Record Key: 49e27446-f6a3-4baa-a75e-8666f481b087

Device Description

Navina Transanal Irrigation. Consumable set regular. 1 Water container, 15 Rectal catheters regular. 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: Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
61094	Rectal irrigation kit	A collection of non-sterile devices intended to be used as part of a rectal irrigation system for the introduction of a non-medicated solution (typically water) into the rectum for patients affected by faecal incontinence or constipation; it is not intended for colostomy site irrigation or irrigation of the entire colon. It includes a rectal catheter and additional non-powered rectal irrigation devices (e.g., fluid container) which may include a single-use device(s). 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	07333387025308	GS1		3	In Commercial Distribution
Primary	07333387025292	GS1
Previous	07392532198403	GS1

Customer Contacts

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