| Primary Device ID | 10846835010121 |
| NIH Device Record Key | ed4b800c-580e-45ef-a5e7-e719c5f065e0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sterile Interface Cable |
| Version Model Number | D133701 |
| Catalog Number | D133701 |
| Company DUNS | 020163218 |
| Company Name | Biosense Webster Inc |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)729-9010 |
| RA-BWIUS-Complaints@its.jnj.com | |
| Phone | +1(800)729-9010 |
| RA-BWIUS-Complaints@its.jnj.com | |
| Phone | +1(800)729-9010 |
| RA-BWIUS-Complaints@its.jnj.com | |
| Phone | +1(800)729-9010 |
| RA-BWIUS-Complaints@its.jnj.com |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10846835010121 [Primary] |
| QZI | Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-19 |
| Device Publish Date | 2024-12-11 |
| 10846835010121 - Sterile Interface Cable | 2024-12-19Cath to Generator CBL Sterile |
| 10846835010121 - Sterile Interface Cable | 2024-12-19 Cath to Generator CBL Sterile |
| 10846835025248 - TRUPULSE™ Generator | 2024-12-19 TRUPULSE Generator |
| 10846835025460 - VARIPULSE™ Bi-Directional Catheter | 2024-12-19 8.5 FR VARIPULSE™ Bi-Directional Catheter |
| 10846835022780 - SOUNDSTAR CRYSTAL Ultrasound Catheter | 2024-07-04 SOUNDSTAR CRYSTAL Ultrasound Catheter |
| 10846835016796 - TX eco EXT Cable | 2023-10-12 TX eco EXT Cable |
| 10846835025811 - OPTRELL Mapping Catheter with TRUEref Technology | 2023-10-12 OPTRELL-36 F-J Curve |
| 10846835025828 - OPTRELL Mapping Catheter with TRUEref Technology | 2023-10-12 OPTRELL-36 D-F Curve |
| 10846835017427 - TX eco Cable | 2023-07-31 TX eco Cable Kit |