Primary Device ID | 04260502640074 |
NIH Device Record Key | 4a2072c9-584e-47ea-bb00-e2643b56ede8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PROGNOST |
Version Model Number | XPE-Akku |
Catalog Number | 7038-9-1703L |
Company DUNS | 314629130 |
Company Name | PROTEC GmbH & Co. KG |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | false |
OTC Over-The-Counter | false |
Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04260502640074 [Primary] |
KXJ | Table, Radiologic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-10-28 |
04260502640074 | Basic x-ray system table, powered |
04260502640067 | Basic x-ray system table, powered |
04260502640050 | Basic x-ray system table, non-powered |
04260502640043 | Basic x-ray system table, non-powered |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PROGNOST 75898278 2661192 Live/Registered |
PROGNOST SYSTEMS GMBH 2000-01-17 |