Navina™ Mini Start Set 6931040

GUDID 07333387052885

Navina Mini Start Set. 1 Water Container, 5 Rectal Cones. 1 Extension Tube. Non Sterile Device.

Wellspect AB

Manual rectal irrigation system

• Primary Device ID: 07333387052885
• NIH Device Record Key: 1a3a0a1e-3b08-4e26-a48f-c70cd1bd260b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navina™ Mini Start Set
• Version Model Number: 6931040
• Catalog Number: 6931040
• Company DUNS: 351118942
• Company Name: Wellspect AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07333387052878 [Primary]
GS1	07333387052885 [Package]; Contains: 07333387052878; Package: [1 Units]; In Commercial Distribution

FDA Product Code

• FCE: Enema kit

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-05
• Device Publish Date: 2024-10-28

Devices Manufactured by Wellspect AB

• 07333387052564 - Navina™ Catheter Set Cone: 2025-01-20 Navina Transanal Irrigation. Rectal Catheter set cone. 10 Rectal catheters cone. Single use. Non sterile Device. Rx Only.
• 07333387052595 - Navina™ Classic System Regular: 2025-01-20 Navina Classic Transanal Irrigation. 1 Navina Classic control unit, 1 Water container, 1 Tube set, 1 Accessory set, 1 Navina cas
• 07333387052618 - Navina™ Classic System Refill: 2025-01-20 Navina Classic Transanal Irrigation. 1 Navina Classic control unit, 1 Water container, 1 Tube set, Non Sterile Device. Rx Only.
• 07333387052632 - Navina™ Smart System: 2025-01-20 Navina Smart Transanal Irrigation. 1 Navina Smart control unit, 1 Water container, 1 Tube set, 1 Accessory set, 1 Navina case. N
• 07333387052854 - Navina Mini Refill Set: 2024-11-05 Navina Mini Refill Set. 30 Rectal Cones. Non Sterile Device.
• 07333387052823 - Navina™ Mini Set: 2024-11-05 Navina Mini Set. 1 Water Container, 30 Rectal Cones. Non Sterile Device.
• 07333387052847 - Navina Mini Extension Set: 2024-11-05 Navina Mini Extension Set. 1 Water Container, 30 Rectal Cones. 1 extension tube. Non Sterile Device.
• 07333387052885 - Navina™ Mini Start Set: 2024-11-05Navina Mini Start Set. 1 Water Container, 5 Rectal Cones. 1 Extension Tube. Non Sterile Device.
• 07333387052885 - Navina™ Mini Start Set: 2024-11-05 Navina Mini Start Set. 1 Water Container, 5 Rectal Cones. 1 Extension Tube. Non Sterile Device.