Primary Device ID | 00627825013550 |
NIH Device Record Key | f689ff4e-12f1-45c6-a97e-9eb9aae9cbdc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | e•Sense 7Fr Dual Sensor Coudé Uretheral Catheter |
Version Model Number | CATEB37C |
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 | 00627825013550 [Primary] |
GS1 | 10627825013557 [Package] Package: [10 Units] In Commercial Distribution |
GS1 | 20627825013554 [Package] Contains: 10627825013557 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 | 2024-12-20 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 | 2024-12-20e•Sense 7Fr Dual Sensor Coudé Uretheral 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 |