Navina™ Accessories

Basic Information

• Brand Name: Navina™ Accessories
• Primary DI: 07333387028125
• Version / Model: 69012
• Catalog Number: 6901200
• Company Name: Wellspect AB
• Labeler DUNS: 351118942
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-25
• Public Version: 2
• Public Version Date: 2023-10-06
• Public Version Status: Update
• Public Device Record Key: 45386db3-c325-49b5-b511-05559d8b808c

Device Description

Navina Accessory set. 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: No
• 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
61651	Rectal/colonic lavage support kit	A collection of non-sterile, noninvasive devices intended to be used in conjunction with a rectal and/or colonic irrigation system to support the introduction of an irrigation solution into the rectum/colon. It includes non-powered, supportive devices typically intended to assist introduction/securing of irrigation devices; it does not include a colonic/rectal irrigation nozzle/catheter. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	07333387028132	GS1		3	In Commercial Distribution
Primary	07333387028125	GS1
Previous	07392532179266	GS1

Customer Contacts

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