Vivid
GUDID 00195278505316
Vivid S60N v206 NOR
GE Vingmed Ultrasound AS
Cardiovascular ultrasound imaging system| Primary Device ID | 00195278505316 |
| NIH Device Record Key | 7dd1fb1d-b0c6-4503-876d-044a1f106608 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vivid |
| Version Model Number | S60N v206 |
| Company DUNS | 518870571 |
| Company Name | GE Vingmed Ultrasound AS |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00195278505316 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K220619
FDA Product Code
| IYN | System, imaging, pulsed doppler, ultrasonic |
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 | 2022-08-22 |
| Device Publish Date | 2022-08-12 |
On-Brand Devices [Vivid]
| 00840682123495 | E95 v202 |
| 00840682123525 | E90 v202 |
| 00840682123488 | E80 v202 |
| 00840682141710 | E95 v203 with LCD |
| 00840682143936 | S v202 to v203 UPG |
| 00840682143189 | E v202 to v203 UPG |
| 00840682142885 | S70N v203 |
| 00840682142861 | S60N v203 |
| 00840682141734 | E80 v203 with LCD |
| 00840682141727 | E90 v203 with LCD |
| 00840682141680 | S60N v203CH |
| 00840682141666 | S70N v203CH |
| 00840682141550 | E80 v203 with OLED |
| 00840682141543 | E90 v203 with OLED |
| 00840682141536 | E95 v203 with OLED |
| 00840682123426 | S70N v202 |
| 00840682123402 | E v201 to v202 UPG |
| 00840682123372 | S60N v202 |
| 00840682123365 | S60N v202CH |
| 00840682123341 | S70N v202CH |
| 00840682121101 | E9 BT11 and BT12 to BT13 XDclear UPG |
| 00840682102735 | E90 v201 |
| 00840682102698 | E95 v201 |
| 00840682147064 | E v203 to v204 UPG |
| 00840682146685 | E95 v204 with LCD |
| 00840682146982 | S70N v204 |
| 00840682146975 | S60N v204CH |
| 00840682146968 | S70N v204CH |
| 00840682146920 | S60N v204 |
| 00840682147156 | S v203 to v204 UPG |
| 00195278341235 | Preown Vivid E95 R4 LCD |
| 00195278435743 | Vivid E v204 4D ICE UPG |
| 00195278276322 | Vivid S60N v205 NOR |
| 00195278276285 | Vivid S70N v205 NOR |
| 00195278276261 | Vivid S60N v205 China |
| 00195278406866 | Vivid S70N S60N v204 to v205 Upg kit |
| 00195278276278 | Vivid S70N v205 China |
| 00840682146654 | Vivid E95 v204 with OLED |
| 00195278516343 | Vivid E95, E90, E80 v203 v204 to v206 UPG |
| 00195278516312 | Vivid S70N S60N v203 v204 v205 to v206 Upg kit |
| 00195278505354 | Vivid E90 v206 |
| 00195278505347 | Vivid E80 v206 |
| 00195278505316 | Vivid S60N v206 NOR |
| 00195278505255 | Vivid S70N v206 NOR |
| 00195278505187 | Vivid S60N v206 China |
| 00195278505170 | Vivid S70N v206 China |
| 00195278505330 | Vivid E95 v206 |
| 00195278916938 | Vivid Pioneer v210 |
Trademark Results [Vivid]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VIVID 98975215 not registered Live/Pending |
GREENFIELD WORLD TRADE, INC. 2023-06-15 |
 VIVID 98685040 not registered Live/Pending |
Marvin Lumber and Cedar Company, LLC 2024-08-06 |
 VIVID 98517528 not registered Live/Pending |
HOYA OPTICAL LABS OF AMERICA INC. 2024-04-24 |
 VIVID 98392182 not registered Live/Pending |
Seattle Cider Co. 2024-02-05 |
 VIVID 98376596 not registered Live/Pending |
LUKOVNIKOV, VALERIY 2024-01-26 |
 VIVID 98232548 not registered Live/Pending |
VIVID Mobile Solutions LLC 2023-10-20 |
 VIVID 98149846 not registered Live/Pending |
TransCore, LP 2023-08-24 |
 VIVID 98128404 not registered Live/Pending |
FCA US LLC 2023-08-11 |
 VIVID 98044528 not registered Live/Pending |
Team International Group of America 2023-06-15 |
 VIVID 98006187 not registered Live/Pending |
Abukhalil, Ayman 2023-05-21 |
 VIVID 97901989 not registered Live/Pending |
RH Studio 2 OpCo 46, Inc. 2023-04-22 |
 VIVID 97698677 not registered Live/Pending |
Maxar Technologies Holdings Inc. 2022-11-30 |
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