Primary Device ID | 00195278711229 |
NIH Device Record Key | a0187477-2610-4de8-8935-4835588f208a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | not applicable |
Version Model Number | PRISTINA 2.8.3 |
Company DUNS | 266062561 |
Company Name | GE MEDICAL SYSTEMS |
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 |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00195278711229 [Primary] |
MUE | Full field digital, system, x-ray, mammographic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-09-22 |
Device Publish Date | 2023-09-14 |
00840682145862 | PRISTINA 0.0A |
00840682142373 | PRISTINA 0.1 |
00840682143516 | PRISTINA 0.0 |
00840682142038 | M3-2 SP1 STD+ |
00840682125802 | M3-2 |
00840682122603 | 5727669 |
00195278009289 | PRISTINA 0.0B |
00840682146845 | Software Pristina Infinity |
00195278716026 | UDI Software Pristina ME 9.1 |
00195278655141 | Software Pristina 8.2 - ISO file |
00195278711229 | UDI Software Pristina |
00195278795724 | Software Pristina 8.3 - ISO file |
00195278719812 | Software Pristina ME 9.2 - ISO file |
00195278866899 | Software Pristina 8.4 - ISO file |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
NOT APPLICABLE 98469202 not registered Live/Pending |
Veterans Plus Home Loans LLC 2024-03-26 |