NaviAid™ SPARK 28-016

GUDID 07290018671528

An inflation system providing controlled inflation and deflation of the NaviAid™ AB balloon.

SMART MEDICAL SYSTEMS LTD

Catheter/overtube balloon inflator, reusable
Primary Device ID07290018671528
NIH Device Record Key6d0c5c42-e116-4793-9883-5788fed7b9b9
Commercial Distribution StatusIn Commercial Distribution
Brand NameNaviAid™ SPARK
Version Model NumberSPARK
Catalog Number28-016
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
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

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 0.7 millibar and 1.1 millibar
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0.7 millibar and 1.1 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.7 millibar and 1.1 millibar
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0.7 millibar and 1.1 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.7 millibar and 1.1 millibar
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0.7 millibar and 1.1 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.7 millibar and 1.1 millibar
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0.7 millibar and 1.1 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.7 millibar and 1.1 millibar
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0.7 millibar and 1.1 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.7 millibar and 1.1 millibar
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0.7 millibar and 1.1 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.7 millibar and 1.1 millibar
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0.7 millibar and 1.1 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.7 millibar and 1.1 millibar
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0.7 millibar and 1.1 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.7 millibar and 1.1 millibar
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0.7 millibar and 1.1 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.7 millibar and 1.1 millibar
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0.7 millibar and 1.1 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.7 millibar and 1.1 millibar
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0.7 millibar and 1.1 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.7 millibar and 1.1 millibar
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0.7 millibar and 1.1 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0.7 millibar and 1.1 millibar
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 0.7 millibar and 1.1 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107290018671528 [Primary]

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 Date2020-12-09
Device Publish Date2020-12-01

Devices Manufactured by SMART MEDICAL SYSTEMS LTD

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
07290018671214 - G-EYE Colonoscope2023-07-26 The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source), documentation equipme
07290018671221 - G-EYE Colonoscope2023-07-26 The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source), documentation equipme
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.