Navina Mini Refill Set

Basic Information

• Brand Name: Navina Mini Refill Set
• Primary DI: 07333387052779
• Version / Model: 6930940
• Catalog Number: 6930940
• Company Name: Wellspect AB
• Labeler DUNS: 351118942
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-28
• Public Version: 1
• Public Version Date: 2024-11-05
• Public Version Status: New
• Public Device Record Key: 898f93e6-9946-4d55-bb26-b580296232a6

Device Description

Navina Mini Refill Set. 30 Rectal Cones. Non Sterile Device.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• 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: Yes
• 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
FCE	Enema kit	Gastroenterology, Urology	876.5210	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61094	Rectal irrigation kit	A collection of devices that includes a rectal irrigation nozzle (also known as a catheter) 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. In addition to the disposable nozzle, it includes a reusable fluid container (e.g., water bag). 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	07333387052854	GS1		30	In Commercial Distribution
Primary	07333387052779	GS1
Package	07333387052861	GS1		1	In Commercial Distribution

Customer Contacts

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