SonoVision

GUDID 00860001239355

SonoVision Ultrasound Imaging Console

Tissue Differentiation Intelligence LLC

General-purpose ultrasound imaging system
Primary Device ID00860001239355
NIH Device Record Key8559d880-b8cb-4a64-bce8-232065341687
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonoVision
Version Model Number100009
Company DUNS081327336
Company NameTissue Differentiation Intelligence LLC
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

Phone305-351-2011
Emailcustomerservice@tissueintel.com
Phone305-351-2011
Emailcustomerservice@tissueintel.com
Phone305-351-2011
Emailcustomerservice@tissueintel.com
Phone305-351-2011
Emailcustomerservice@tissueintel.com
Phone305-351-2011
Emailcustomerservice@tissueintel.com
Phone305-351-2011
Emailcustomerservice@tissueintel.com
Phone305-351-2011
Emailcustomerservice@tissueintel.com
Phone305-351-2011
Emailcustomerservice@tissueintel.com
Phone305-351-2011
Emailcustomerservice@tissueintel.com
Phone305-351-2011
Emailcustomerservice@tissueintel.com
Phone305-351-2011
Emailcustomerservice@tissueintel.com
Phone305-351-2011
Emailcustomerservice@tissueintel.com
Phone305-351-2011
Emailcustomerservice@tissueintel.com
Phone305-351-2011
Emailcustomerservice@tissueintel.com
Phone305-351-2011
Emailcustomerservice@tissueintel.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 101 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *This End Up
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 101 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *This End Up
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 101 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *This End Up
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 101 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *This End Up
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 101 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *This End Up
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 101 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *This End Up
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 101 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *This End Up
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 101 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *This End Up
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 101 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *This End Up
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 101 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *This End Up
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 101 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *This End Up
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 101 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *This End Up
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 101 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *This End Up
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 101 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *This End Up
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 101 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *This End Up

Device Identifiers

Device Issuing AgencyDevice ID
GS100860001239355 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYNSystem, Imaging, Pulsed Doppler, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-11
Device Publish Date2022-03-03

On-Brand Devices [SonoVision]

00860001239355SonoVision Ultrasound Imaging Console
00860001239300SonoVision Accessory Kit

Trademark Results [SonoVision]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SONOVISION
SONOVISION
90870796 not registered Live/Pending
Tissue Differentiation Intelligence, LLC
2021-08-07
SONOVISION
SONOVISION
88243428 not registered Live/Pending
Tissue Differentiation Intelligence, LLC.
2018-12-27
SONOVISION
SONOVISION
85828735 4476122 Live/Registered
Flight Test Aerospace, Inc.
2013-01-22
SONOVISION
SONOVISION
79272756 not registered Live/Pending
SONOVISION
2019-06-07
SONOVISION
SONOVISION
78483361 not registered Dead/Abandoned
Zubr Comm., LLC
2004-09-14
SONOVISION
SONOVISION
77122350 not registered Dead/Abandoned
Stork Vision Brand LLC
2007-03-05
SONOVISION
SONOVISION
73437800 1343886 Dead/Cancelled
Cochlea Corp.
1983-08-04

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