Primary Device ID | 00840682124324 |
NIH Device Record Key | d0c4f1c8-9c83-4aaa-9df8-87021ba15f7a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | LOGIQ E9 |
Version Model Number | 5205000-8 |
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 | 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 |
Height | 1300 Millimeter |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00840682124324 [Primary] |
IYN | System, imaging, pulsed doppler, ultrasonic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2017-03-22 |
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 | 2024-07-18 Venue Sprint R5 MD |
00195278680938 - LOGIQ | 2023-12-12 LOGIQ E10 R4 Console |