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
Primary Device ID17290018671662
NIH Device Record Key7330c094-d6c8-4a16-b7c3-c618bd06a592
Commercial Distribution StatusIn Commercial Distribution
Brand NameNaviAid™ ABC
Version Model NumberABC
Catalog Number23-010
Company DUNS649905544
Company NameSMART MEDICAL SYSTEMS LTD
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+97297444321
Emailinfo@smartmedsys.com
Phone+97297444321
Emailinfo@smartmedsys.com
Phone+97297444321
Emailinfo@smartmedsys.com
Phone+97297444321
Emailinfo@smartmedsys.com
Phone+97297444321
Emailinfo@smartmedsys.com
Phone+97297444321
Emailinfo@smartmedsys.com
Phone+97297444321
Emailinfo@smartmedsys.com
Phone+97297444321
Emailinfo@smartmedsys.com
Phone+97297444321
Emailinfo@smartmedsys.com
Phone+97297444321
Emailinfo@smartmedsys.com
Phone+97297444321
Emailinfo@smartmedsys.com
Phone+97297444321
Emailinfo@smartmedsys.com
Phone+97297444321
Emailinfo@smartmedsys.com
Phone+97297444321
Emailinfo@smartmedsys.com
Phone+97297444321
Emailinfo@smartmedsys.com
Phone+97297444321
Emailinfo@smartmedsys.com
Phone+97297444321
Emailinfo@smartmedsys.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290018671658 [Primary]
GS117290018671662 [Package]
Contains: 07290018671658
Package: 5 units carton box [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODCEndoscope Channel Accessory

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-22
Device Publish Date2024-01-14

Devices Manufactured by SMART MEDICAL SYSTEMS LTD

17290018671662 - NaviAid™ ABC2024-01-22The 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™ ABC2024-01-22 The NaviAid™ ABC device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope during e
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07290018671238 - G-EYE Colonoscope2023-07-26 The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source), documentation equipme
07290018671245 - G-EYE Colonoscope2023-07-26 The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source), documentation equipme
07290018671252 - G-EYE Colonoscope2023-07-26 The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source), documentation equipme
07290018671269 - G-EYE Colonoscope2023-07-26 The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source), documentation equipme
07290018671276 - G-EYE Colonoscope2023-07-26 The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source), documentation equipme

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