NaviAid™ ABC 23-010

GUDID 17290018671662

The NaviAid™ ABC device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope during endoscopy of the small and large intestine (standard endoscope-i.e., an endoscope that has an instrument channel that is at least 3.7mm diameter and is used for standard endoscopic visualization). The NaviAid™ ABC Device is comprised of a balloon catheter (‘ABC 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™ ABC 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 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: 17290018671662
• NIH Device Record Key: 7330c094-d6c8-4a16-b7c3-c618bd06a592
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NaviAid™ ABC
• Version Model Number: ABC
• Catalog Number: 23-010
• Company DUNS: 649905544
• Company Name: SMART MEDICAL SYSTEMS LTD
• Device Count: 1
• DM Exempt: true
• 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
• 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	07290018671658 [Primary]
GS1	17290018671662 [Package]; Contains: 07290018671658; Package: 5 units carton box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111760

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: 2024-01-22
• Device Publish Date: 2024-01-14

Devices Manufactured by SMART MEDICAL SYSTEMS LTD

• 17290018671662 - NaviAid™ ABC: 2024-01-22The NaviAid™ ABC device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope during endoscopy of the small and large intestine (standard endoscope-i.e., an endoscope that has an instrument channel that is at least 3.7mm diameter and is used for standard endoscopic visualization). The NaviAid™ ABC Device is comprised of a balloon catheter (‘ABC 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™ ABC Device is indicated for use in adults and adolescent population.
• 17290018671662 - NaviAid™ ABC: 2024-01-22 The NaviAid™ ABC device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope during e
• 07290018671214 - G-EYE Colonoscope: 2023-07-26 The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source), documentation equipme
• 07290018671221 - G-EYE Colonoscope: 2023-07-26 The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source), documentation equipme
• 07290018671238 - G-EYE Colonoscope: 2023-07-26 The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source), documentation equipme
• 07290018671245 - G-EYE Colonoscope: 2023-07-26 The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source), documentation equipme
• 07290018671252 - G-EYE Colonoscope: 2023-07-26 The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source), documentation equipme
• 07290018671269 - G-EYE Colonoscope: 2023-07-26 The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source), documentation equipme
• 07290018671276 - G-EYE Colonoscope: 2023-07-26 The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source), documentation equipme