Navina™ Smart App for iOS

Basic Information

• Brand Name: Navina™ Smart App for iOS
• Primary DI: 07333387030388
• Version / Model: 75750
• Catalog Number: 75750
• 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: edc0198f-f307-446f-9ffe-59e6904c09d6

Device Description

Navina Smart Transanal Irrigation. Bowel diary APP

Device Characteristics

• Single Use: No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
OUG	Medical device data system	General Hospital	880.6310	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61114	Rectal irrigation system application software	An application software program intended to store and display data relating to rectal irrigation procedures (e.g., volumes of water used) to assist a review/evaluation of the procedure; it is not intended to store patient clinical data, control the system, or make recommendations to the user. It is typically for installation in an off-the-shelf desktop, laptop, tablet computer or smartphone, which will require a connection to the rectal irrigation system control unit to automatically receive data. It is intended to be used in the home and healthcare facility. It typically includes upgrades to the software.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07333387030388	GS1
Previous	07392532242373	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.