Primary Device ID | 00198953001103 |
NIH Device Record Key | 1863c6b8-a8b1-48a0-a20d-9089ccbbf94e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Venue Fit |
Version Model Number | R6 |
Company DUNS | 119309548 |
Company Name | Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc |
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 |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00198953001103 [Primary] |
ITX | Transducer, Ultrasonic, Diagnostic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-08-08 |
Device Publish Date | 2025-07-31 |
00198953001073 - Venue | 2025-08-08 Venue R6 final Assembly |
00198953001097 - Venue Go | 2025-08-08 Venue Go R6 Final Assembly |
00198953001103 - Venue Fit | 2025-08-08Venue Fit R6 Final Assembly |
00198953001103 - Venue Fit | 2025-08-08 Venue Fit R6 Final Assembly |
00198953001387 - Venue Sprint | 2025-08-08 Venue Sprint R6 MD |
00198953030233 - Caption | 2025-08-05 Caption AI on Vscan |
00195278756138 - Invenia | 2025-03-20 Invenia ABUS Prime |
00195278756237 - Invenia | 2025-03-12 Invenia ABUS Premium |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() VENUE FIT 88861098 not registered Live/Pending |
GE PRECISION HEALTHCARE LLC 2020-04-06 |