Venue Fit
GUDID 00195278703224
Venue Fit R5 Final Assembly
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
General-purpose ultrasound imaging system| Primary Device ID | 00195278703224 |
| NIH Device Record Key | fd176de7-365d-4ac4-af95-dd7f62ae2463 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Venue Fit |
| Version Model Number | R5 |
| Company DUNS | 078863378 |
| 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 | false |
| 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
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 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 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 |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 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 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 |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 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 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 |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 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 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 |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 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 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 |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 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 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 |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 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 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 |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 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 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 |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 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 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 |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 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 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 |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 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 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 |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 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 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 |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 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 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 |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 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 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 |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 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 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 |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 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 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 |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00195278703224 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K234106
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 | 2024-07-18 |
| Device Publish Date | 2024-07-10 |
On-Brand Devices [Venue Fit]
| 00195278194275 | Venue Fit final Assy. |
| 00195278516497 | Venue Fit R4 Final Assembly |
| 00195278513014 | Venue Fit R4 MD either eDelivery or physical |
| 00195278703484 | Venue Fit R5 MD |
| 00195278703224 | Venue Fit R5 Final Assembly |
Trademark Results [Venue Fit]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VENUE FIT 88861098 not registered Live/Pending |
GE PRECISION HEALTHCARE LLC 2020-04-06 |
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