Navina™ Rectal Catheter set regular

Basic Information

• Brand Name: Navina™ Rectal Catheter set regular
• Primary DI: 07392532168499
• Version / Model: 68940
• Catalog Number: 6894040
• Company Name: Wellspect AB
• Labeler DUNS: 351118942
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-10
• Public Version: 6
• Public Version Date: 2023-09-26
• Public Version Status: Update
• Public Device Record Key: 442bef80-a0a2-4ab1-9b8b-9ed342d4694b
• Distribution End Date: 2024-03-31

Device Description

Navina Transanal Irrigation. Rectal Catheter set regular. 10 Rectal catheters regular. Single use. Non sterile Device. Rx Only.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
KNT	TUBES, GASTROINTESTINAL (AND ACCESSORIES)	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46202	Rectal irrigation system catheter	A flexible tube that is a component of a rectal irrigation system and designed to be inserted into the rectum (may be held in position by an inflatable retention balloon) where it serves as a conduit for water introduced into the rectum. The irrigation is typically used to provoke the defecation reflex for the evacuation of the bowels to treat/prevent constipation and reduce the risk of faecal incontinence. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	07392532198380	GS1		30	In Commercial Distribution	2024-03-30
Package	07392532198373	GS1		10	In Commercial Distribution	2024-03-30
Primary	07392532168499	GS1

Customer Contacts

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