Home GUDID 07290018671603
NaviAid™ AB
Primary DI 07290018671603
Brand NaviAid™ AB
Company SMART MEDICAL SYSTEMS LTD
Model AB-F
Catalog number 24-010
Device description The NaviAid™ AB device is an accessory to an endoscope and is intended to ensure positioning of a standardendoscope in the small intestine. It enables the advancement of a standard endoscope into the small intestinewhile utilizing the existing endoscope optics and utilities.The NaviAid™ AB Device is comprised of a balloon catheter (‘AB Disposable’) which is inserted through theinstrument channel of the endoscope, similarly to other endoscopic accessories, and a supporting single balloonair supply and control unit – NaviAid™ SPARK (‘SPARK’) for providing controlled inflation and deflation of theballoon.The NaviAid™ AB Device is indicated for use in adults and adolescent population.
Published 2020-12-01
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
Single use true
Product Codes# Code, Name table Code Name ODC Endoscope Channel Accessory
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ODC Endoscope Channel Accessory Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 17290018671617 Package GS1 5 In Commercial Distribution 27290018671621 Package GS1 10 In Commercial Distribution 07290018671603 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 17290018671617 17290018671617 27290018671621 27290018671621 07290018671603 07290018671603 7290018671603
GMDN Terms# Term, Definition table Term Definition Catheter/overtube balloon inflator, single-use A device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device.
Regulatory Flags# DUNS number 649905544 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850050934196 EndoSound® Biopsy Port Adapter 5054 Endosound, Inc. ODC 2026-06-01 00850050934202 EndoSound® Biopsy Port Adapter (5 pack) 5064 Endosound, Inc. ODC 2026-06-01 00724995246693 DEFENDO Disposable Biopsy Valve MEDIVATORS INC. ODC 2026-04-06 00724995246709 DEFENDO Disposable Biopsy Valve MEDIVATORS INC. ODC 2026-04-06 00724995246716 DEFENDO Biopsy Valve Irrigator MEDIVATORS INC. ODC 2026-04-06 00724995246723 DEFENDO Air/Water/Suction and Biopsy Valve MEDIVATORS INC. ODC 2026-04-06 00724995246730 DEFENDO Air/Water and Suction Valves MEDIVATORS INC. ODC 2026-04-06 00724995246747 DEFENDO Valve and Connector Kit MEDIVATORS INC. ODC 2026-04-06 00724995246754 Defendo Single Use Valve Kit MEDIVATORS INC. ODC 2026-04-06 00724995246761 Defendo Single Use Valve Kit MEDIVATORS INC. ODC 2026-04-06 00724995246778 Defendo Single Use Valve Kit MEDIVATORS INC. ODC 2026-04-06 00724995246785 Defendo Single Use Valve Kit MEDIVATORS INC. ODC 2026-04-06 00724995246792 DEFENDO Valve and Connector Kit MEDIVATORS INC. ODC 2026-04-06 00724995246808 DEFENDO Air/Water/Suction and Biopsy Valve MEDIVATORS INC. ODC 2026-04-06 00724995246815 DEFENDO Air/Water and Suction Valves MEDIVATORS INC. ODC 2026-04-06 00724995246846 DEFENDO SINGLE USE VALVE KIT MEDIVATORS INC. ODC 2026-04-06 04897106957880 andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit GA Health Company Limited ODC 2026-03-13 04897106957897 andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit GA Health Company Limited ODC 2026-03-13 04897106957941 andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit GA Health Company Limited ODC 2026-03-13 04897106957958 andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit GA Health Company Limited ODC 2026-03-13 04897106957910 andorate® 4-piece valve kit GA Health Company Limited ODC 2026-03-12 00724995247300 NA MEDIVATORS INC. ODC 2026-03-02 04897106957972 andorate® 3-piece Valve Kit GA Health Company Limited ODC 2026-02-27 04897106957835 Champion 3-piece valve kit GA Health Company Limited ODC 2026-01-21 04897106957842 Champion 3-piece valve kit GA Health Company Limited ODC 2026-01-21 04897106957859 Champion 4-piece valve kit GA Health Company Limited ODC 2026-01-21 04897106957866 Air Water Channel Cleaning Adapter + Champion 3-piece Valve Kit GA Health Company Limited ODC 2026-01-21 04897106957903 Champion 3-piece valve kit GA Health Company Limited ODC 2026-01-21 04897106957927 Air Water Channel Cleaning Adapter + Champion 3-piece Valve Kit GA Health Company Limited ODC 2026-01-21 04897106957934 Air Water Channel Cleaning Adapter + Champion 4-piece Valve Kit GA Health Company Limited ODC 2026-01-21