Navina™ Classic System Regular 6910540

GUDID 07333387052595

Navina Classic Transanal Irrigation. 1 Navina Classic control unit, 1 Water container, 1 Tube set, 1 Accessory set, 1 Navina case. Non Sterile Device. Rx Only.

Wellspect AB

Manual rectal irrigation system

• Primary Device ID: 07333387052595
• NIH Device Record Key: 63dc35f0-eafe-4606-bdeb-4877f439ca86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navina™ Classic System Regular
• Version Model Number: 69105
• Catalog Number: 6910540
• Company DUNS: 351118942
• Company Name: Wellspect AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• OTC Over-The-Counter: false

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07333387052588 [Primary]
GS1	07333387052595 [Package]; Contains: 07333387052588; Package: [1 Units]; In Commercial Distribution

FDA Product Code

• KNT: Tubes, gastrointestinal (and accessories)

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: 2025-01-20
• Device Publish Date: 2025-01-10

On-Brand Devices [Navina™ Classic System Regular]

• 07333387025803: Navina Classic Transanal Irrigation. 1 Navina Classic control unit, 1 Water container, 1 Tube se
• 07333387052595: Navina Classic Transanal Irrigation. 1 Navina Classic control unit, 1 Water container, 1 Tube se