FDA.reportPublic FDA data

Urodynamic manometric catheter, electronic, single-use

Definition
A sterile flexible tube with electronic pressure sensors at the distal end intended to be inserted into the bladder via the urethra for measuring urethral/bladder pressure. Also known as a urodynamic solid-state sensor catheter, it is intended for proximal connection to appropriate equipment for urodynamic examination of a patient, and may have a lumen to fill/drain the bladder to facilitate pressure measurement. This is a single-use device.
GUDID devices
30
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00627825013536e•Sense 7Fr Single Sensor Coudé Bladder CatheterLaborie Medical Technologies Corp.CATEB27C2024-12-12
00627825013543e•Sense 7Fr Dual Sensor Urethral CatheterLaborie Medical Technologies Corp.CATEB372024-12-12
00801741039317Bard® Urodynamic Catheter, Single LumenC. R. Bard, Inc.6614312016-08-06
00801741039324Bard® Urodynamic Catheter, Triple LumenC. R. Bard, Inc.6614332016-08-06
00801741039331Bard® Urodynamic Catheter, Double LumenC. R. Bard, Inc.6614342016-08-06
00801741039348Bard® Urodynamic Catheter, Triple LumenC. R. Bard, Inc.6614352016-08-06
00801741039355Bard® Urodynamic Catheter, Triple LumenC. R. Bard, Inc.6614402016-08-06
00801741039362Bard® Urodynamic Catheter, Triple LumenC. R. Bard, Inc.6614412016-08-06
00801741045769Bard® Urodynamic Pump Tubing SetC. R. Bard, Inc.6615012016-07-28
00801741046490Bard® Urodynamic Catheter, Triple LumenC. R. Bard, Inc.661435R2016-08-06
00801741046506Bard® Urodynamic Catheter, Triple LumenC. R. Bard, Inc.661435S2016-08-06
00888937011159Lumax TS ProCoopersurgical, Inc.10307-0052016-05-09
00888937011173Lumax TS ProCoopersurgical, Inc.10307-0102016-05-09
10627825014844T-DOC 5Fr Air-Charged Abdominal Sensor CatheterLaborie Medical Technologies Corp.CAT5752024-12-12
10627825014851T-DOC 5Fr Air-Charged Single Sensor CatheterLaborie Medical Technologies Corp.CAT595P2024-12-12
10627825014868T-DOC 5Fr Air-Charged Single Sensor CatheterLaborie Medical Technologies Corp.CAT595S2024-12-12
00086000980061GleanBright Uro, IncGUS-1000-F2025-09-23
00860009800601GleanBright Uro, IncGUS-1000-M2025-09-23
00860009800649GleanBright Uro, IncGUS-1000-M2025-09-23
00860009800656GleanBright Uro, IncGUS-1000-F2025-09-23
00627825013529e•Sense 7Fr Single Sensor Bladder CatheterLaborie Medical Technologies Corp.CATEB272024-12-12
00627825013550e•Sense 7Fr Dual Sensor Coudé Uretheral CatheterLaborie Medical Technologies Corp.CATEB37C2024-12-12
00627825013567e•Sense 7Fr Abdominal CatheterLaborie Medical Technologies Corp.CATEA172024-12-12
10627825013533e•Sense 7Fr Single Sensor Coudé Bladder CatheterLaborie Medical Technologies Corp.CATEB27C2024-12-12
10627825013540e•Sense 7Fr Dual Sensor Urethral CatheterLaborie Medical Technologies Corp.CATEB372024-12-12
20627825014841T-DOC 5Fr Air-Charged Abdominal Sensor CatheterLaborie Medical Technologies Corp.CAT5752024-12-12
20627825014858T-DOC 5Fr Air-Charged Single Sensor CatheterLaborie Medical Technologies Corp.CAT595P2024-12-12
20627825014865T-DOC 5Fr Air-Charged Single Sensor CatheterLaborie Medical Technologies Corp.CAT595S2024-12-12
20888937011153Lumax TS ProCoopersurgical, Inc.10307-0052016-05-09
20888937011177Lumax TS ProCoopersurgical, Inc.10307-0102016-05-09