Venue Sprint
GUDID 00195278754011
Venue Sprint R5 MD
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
Ultrasound imaging system application software| Primary Device ID | 00195278754011 |
| NIH Device Record Key | d743ff68-8086-47b2-895d-21495cd7403e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Venue Sprint |
| 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 | true |
| Serial Number | false |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00195278754011 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K240206
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 | 2024-07-18 |
| Device Publish Date | 2024-07-10 |
Devices Manufactured by GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
| 00195278687777 - Venue Go | 2024-07-18 Venue Go R5 MD |
| 00195278703200 - Venue | 2024-07-18 Venue R5 final Assembly |
| 00195278703224 - Venue Fit | 2024-07-18 Venue Fit R5 Final Assembly |
| 00195278703453 - Venue Go | 2024-07-18 Venue Go R5 Final Assembly |
| 00195278703477 - Venue | 2024-07-18 Venue R5 MD |
| 00195278703484 - Venue Fit | 2024-07-18 Venue Fit R5 MD |
| 00195278754011 - Venue Sprint | 2024-07-18Venue Sprint R5 MD |
| 00195278754011 - Venue Sprint | 2024-07-18 Venue Sprint R5 MD |
| 00195278680938 - LOGIQ | 2023-12-12 LOGIQ E10 R4 Console |
Trademark Results [Venue Sprint]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VENUE SPRINT 98095519 not registered Live/Pending |
GE HealthCare Medical Technology LLC 2023-07-21 |
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