| Primary Device ID | 00627825013529 |
| NIH Device Record Key | e6502a22-bbfa-43e0-9bee-cfae3cdd5f63 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | e•Sense 7Fr Single Sensor Bladder Catheter |
| Version Model Number | CATEB27 |
| Company DUNS | 117783313 |
| Company Name | Laborie Medical Technologies Corp. |
| 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 | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00627825013529 [Primary] |
| GS1 | 10627825013526 [Package] Package: [10 Units] In Commercial Distribution |
| GS1 | 20627825013523 [Package] Contains: 10627825013526 Package: [100 Units] In Commercial Distribution |
| FEN | Device, Cystometric, Hydraulic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-20 |
| Device Publish Date | 2024-12-12 |
| 00627825013529 - e•Sense 7Fr Single Sensor Bladder Catheter | 2024-12-20e•Sense 7Fr Single Sensor Bladder Catheter |
| 00627825013529 - e•Sense 7Fr Single Sensor Bladder Catheter | 2024-12-20 e•Sense 7Fr Single Sensor Bladder Catheter |
| 10627825013533 - e•Sense 7Fr Single Sensor Coudé Bladder Catheter | 2024-12-20 e•Sense 7Fr Single Sensor Coudé Bladder Catheter |
| 10627825013540 - e•Sense 7Fr Dual Sensor Urethral Catheter | 2024-12-20 e•Sense 7Fr Dual Sensor Urethral Catheter |
| 00627825013550 - e•Sense 7Fr Dual Sensor Coudé Uretheral Catheter | 2024-12-20 e•Sense 7Fr Dual Sensor Coudé Uretheral Catheter |
| 00627825013567 - e•Sense 7Fr Abdominal Catheter | 2024-12-20 e•Sense 7Fr Abdominal Catheter |
| 20627825014841 - T-DOC 5Fr Air-Charged Abdominal Sensor Catheter | 2024-12-20 T-DOC 5Fr Air-Charged Abdominal Sensor Catheter |
| 20627825014858 - T-DOC 5Fr Air-Charged Single Sensor Catheter | 2024-12-20 T-DOC 5Fr Air-Charged Single Sensor Catheter |
| 20627825014865 - T-DOC 5Fr Air-Charged Single Sensor Catheter | 2024-12-20 T-DOC 5Fr Air-Charged Single Sensor Catheter with stylet |