Versana
GUDID 00195278300034
Supra R2 basic console for Balance VS
GE Medical Systems (China) Co.,Ltd.
General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system| Primary Device ID | 00195278300034 |
| NIH Device Record Key | c38dd3f6-0f24-46a7-88bb-f35d748e2746 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Versana |
| Version Model Number | Balance R2 VS |
| Company DUNS | 654658731 |
| Company Name | GE Medical Systems (China) Co.,Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery. |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery. |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery. |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery. |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery. |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery. |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery. |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery. |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery. |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery. |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery. |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery. |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery. |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery. |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery. |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery. |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 3 degree C to 40 degree C without battery. |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handing environment temperature from 10 degree C to 30 degree C with battery |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00195278300034 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K220446
FDA Product Code
| ITX | Transducer, ultrasonic, diagnostic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-23 |
| Device Publish Date | 2023-06-15 |
On-Brand Devices [Versana]
| 00840682142625 | Active |
| 00840682142618 | Balance VA |
| 00840682142595 | Balance VS |
| 00840682141178 | Premier VA |
| 00840682141147 | Premier VS |
| 00840682147194 | Active R1.5 UPG |
| 00840682147033 | Active 1.5 |
| 00840682146296 | Premier SW R1.1.x UPG |
| 00840682180542 | Magna R2 VA Basic console |
| 00840682180535 | Magna R2 VS Basic console |
| 00195278503411 | Versana Essiential R2 VA |
| 00195278503404 | Versana Essential R2 VS |
| 00195278300096 | Supra R2 basic console for Balance VA |
| 00195278300034 | Supra R2 basic console for Balance VS |
Trademark Results [Versana]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VERSANA 97320098 not registered Live/Pending |
Syndicated Loan Consortium TechnologiesLLC 2022-03-18 |
 VERSANA 87413283 not registered Dead/Abandoned |
General Electric Company 2017-04-17 |
 VERSANA 87001755 5032057 Live/Registered |
TADIN, LLC 2016-04-15 |
 VERSANA 85541106 not registered Dead/Abandoned |
AmeriHealth Mercy Health Plan 2012-02-13 |
 VERSANA 77274838 3562067 Dead/Cancelled |
Gonzales-Blanco, Jose M. 2007-09-07 |
 VERSANA 76622541 not registered Dead/Abandoned |
ZHOU FENG FEI 2004-11-29 |
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