Primary Device ID | 04260166373134 |
NIH Device Record Key | c82dc538-1b7c-43af-ac21-b3068d35da8d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | INTELLAGEN™ Irrigation Pump Connection Cable (5m) |
Version Model Number | 19946 |
Catalog Number | M004GEN100199460 |
Company DUNS | 327536314 |
Company Name | Stockert GmbH |
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 | 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 |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Keep away from sunlight |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Keep away from sunlight |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Keep away from sunlight |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Keep away from sunlight |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Keep away from sunlight |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Keep away from sunlight |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Keep away from sunlight |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Keep away from sunlight |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Keep away from sunlight |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Keep away from sunlight |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Keep away from sunlight |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Keep away from sunlight |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Keep away from sunlight |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Keep away from sunlight |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Keep away from sunlight |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Keep away from sunlight |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Keep away from sunlight |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04260166373134 [Primary] |
OAD | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-09-09 |
Device Publish Date | 2024-09-01 |
04260166373066 - INTELLAGEN™ Foot Pedal | 2024-09-09 |
04260166373080 - INTELLAGEN™ Grounding Cable (3m) | 2024-09-09 |
04260166373097 - INTELLAGEN™ ECG Connection Cable (3m) | 2024-09-09 |
04260166373103 - INTELLAGEN™ Serial Communication Cable (5m) | 2024-09-09 |
04260166373110 - INTELLAGEN™ Serial Communication Cable (15m) | 2024-09-09 |
04260166373127 - INTELLAGEN™ Remote Control Connection Cable (25m) | 2024-09-09 |
04260166373134 - INTELLAGEN™ Irrigation Pump Connection Cable (5m) | 2024-09-09 |
04260166373134 - INTELLAGEN™ Irrigation Pump Connection Cable (5m) | 2024-09-09 |
04260166373158 - INTELLAGEN™ Catheter Adapter Cable (0.3m) | 2024-09-09 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
INTELLAGEN 98550182 not registered Live/Pending |
Boston Scientific Scimed, Inc. 2024-05-14 |
INTELLAGEN 98087988 not registered Live/Pending |
Jaquish Biomedical Corporation 2023-07-17 |
INTELLAGEN 90332956 not registered Live/Pending |
Boston Scientific Scimed, Inc. 2020-11-20 |