NaviAid™ AB 24-010

GUDID 07290018671603

The NaviAid™ AB device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope in the small intestine. It enables the advancement of a standard endoscope into the small intestine while utilizing the existing endoscope optics and utilities. The NaviAid™ AB Device is comprised of a balloon catheter (‘AB Disposable’) which is inserted through the instrument channel of the endoscope, similarly to other endoscopic accessories, and a supporting single balloon air supply and control unit – NaviAid™ SPARK (‘SPARK’) for providing controlled inflation and deflation of the balloon.The NaviAid™ AB Device is indicated for use in adults and adolescent population.

SMART MEDICAL SYSTEMS LTD

Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use

• Primary Device ID: 07290018671603
• NIH Device Record Key: f47b0356-749f-46c7-a645-f81ca127b515
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NaviAid™ AB
• Version Model Number: AB-F
• Catalog Number: 24-010
• Company DUNS: 649905544
• Company Name: SMART MEDICAL SYSTEMS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290018671603 [Primary]
GS1	17290018671617 [Package]; Package: 5 unit carton box [5 Units]; In Commercial Distribution
GS1	27290018671621 [Package]; Package: 10 unit carton box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112106

FDA Product Code

• ODC: Endoscope Channel Accessory

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: 2020-12-09
• Device Publish Date: 2020-12-01

On-Brand Devices [NaviAid™ AB]

• 07290018671603: The NaviAid™ AB device is an accessory to an endoscope and is intended to ensure positioning o
• 07290018671634: Device Description (max 2000 characters): The NaviAid™ AB device is an accessory to an endosc