NaviAid™ AB 31-010

GUDID 07290018671634

Device Description (max 2000 characters): 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
Primary Device ID07290018671634
NIH Device Record Key63694571-0ff3-42e0-a58e-fdfc36baa9d3
Commercial Distribution StatusIn Commercial Distribution
Brand NameNaviAid™ AB
Version Model NumberAB-R
Catalog Number31-010
Company DUNS649905544
Company NameSMART MEDICAL SYSTEMS LTD
Device Count1
DM Exemptfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107290018671634 [Primary]
GS117290018671648 [Package]
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 Date2020-12-10
Device Publish Date2020-12-02

On-Brand Devices [NaviAid™ AB]

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

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