Versana

GUDID 00195278300034

Supra R2 basic console for Balance VS

GE Medical Systems (China) Co.,Ltd.

General-purpose ultrasound imaging system
Primary Device ID00195278300034
NIH Device Record Keyc38dd3f6-0f24-46a7-88bb-f35d748e2746
Commercial Distribution StatusIn Commercial Distribution
Brand NameVersana
Version Model NumberBalance R2 VS
Company DUNS654658731
Company NameGE Medical Systems (China) Co.,Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery.
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery.
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery.
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery.
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery.
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery.
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery.
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery.
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery.
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery.
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery.
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery.
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery.
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery.
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery.
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery.
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery.
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100195278300034 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-23
Device Publish Date2023-06-15

On-Brand Devices [Versana]

00840682142625Active
00840682142618Balance VA
00840682142595Balance VS
00840682141178Premier VA
00840682141147Premier VS
00840682147194Active R1.5 UPG
00840682147033Active 1.5
00840682146296Premier SW R1.1.x UPG
00840682180542Magna R2 VA Basic console
00840682180535Magna R2 VS Basic console
00195278503411Versana Essiential R2 VA
00195278503404Versana Essential R2 VS
00195278300096Supra R2 basic console for Balance VA
00195278300034Supra R2 basic console for Balance VS
00195278690395Magna R3 VA Basic console
00195278690388Magna R3 VS Basic console
00195278690418Magna R3 LOTUS 5pp Basic console
00195278690401Magna R3 LOTUS 4pp Basic console

Trademark Results [Versana]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VERSANA
VERSANA
97320098 not registered Live/Pending
Syndicated Loan Consortium TechnologiesLLC
2022-03-18
VERSANA
VERSANA
87413283 not registered Dead/Abandoned
General Electric Company
2017-04-17
VERSANA
VERSANA
87001755 5032057 Live/Registered
TADIN, LLC
2016-04-15
VERSANA
VERSANA
85541106 not registered Dead/Abandoned
AmeriHealth Mercy Health Plan
2012-02-13
VERSANA
VERSANA
77274838 3562067 Dead/Cancelled
Gonzales-Blanco, Jose M.
2007-09-07
VERSANA
VERSANA
76622541 not registered Dead/Abandoned
ZHOU FENG FEI
2004-11-29

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