FDA.reportPublic FDA data

e•Sense 7Fr Dual Sensor Coudé Uretheral Catheter

Primary DI
00627825013550
Brand
e•Sense 7Fr Dual Sensor Coudé Uretheral Catheter
Company
Laborie Medical Technologies Corp.
Model
CATEB37C
Device description
e•Sense 7Fr Dual Sensor Coudé Uretheral Catheter
Published
2024-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FENDevice, Cystometric, Hydraulic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FENDevice, Cystometric, HydraulicGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10627825013557PackageGS110In Commercial Distribution
20627825013554PackageGS1100In Commercial Distribution
00627825013550PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1062782501355710627825013557
2062782501355420627825013554
00627825013550006278250135506278250135500627825013550

GMDN Terms#

Term, Definition table
TermDefinition
Urodynamic manometric catheter, electronic, single-useA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117783313
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20627825008550TENS/EMS Electrode Procedure PackDIS70002026-05-19
10627825014844T-DOC 5Fr Air-Charged Abdominal Sensor CatheterCAT5752024-12-12
10627825014851T-DOC 5Fr Air-Charged Single Sensor CatheterCAT595P2024-12-12
10627825014868T-DOC 5Fr Air-Charged Single Sensor CatheterCAT595S2024-12-12
00627825014830SOLAR Anorectal Manometry CatheterK1210AC-L-22122025-03-06
00627825014823SOLAR Anorectal Manometry ChargerZM12-AC59-22132025-03-06
10627825014837SOLAR Anorectal Manometry CatheterK1210AC-L-22122025-03-06
08720648846052SOLAR CompactG4-12025-03-06
08720648846069PIM NXT for eSensePIX70002025-02-21
00627825013536e•Sense 7Fr Single Sensor Coudé Bladder CatheterCATEB27C2024-12-12
00627825013543e•Sense 7Fr Dual Sensor Urethral CatheterCATEB372024-12-12
00627825013529e•Sense 7Fr Single Sensor Bladder CatheterCATEB272024-12-12
10627825013533e•Sense 7Fr Single Sensor Coudé Bladder CatheterCATEB27C2024-12-12
10627825013540e•Sense 7Fr Dual Sensor Urethral CatheterCATEB372024-12-12
00627825013567e•Sense 7Fr Abdominal CatheterCATEA172024-12-12
20627825014841T-DOC 5Fr Air-Charged Abdominal Sensor CatheterCAT5752024-12-12
20627825014858T-DOC 5Fr Air-Charged Single Sensor CatheterCAT595P2024-12-12
20627825014865T-DOC 5Fr Air-Charged Single Sensor CatheterCAT595S2024-12-12
00627825014540Urostym EMG Stimulation Cable, Ch 1CAB8962022-11-10
00627825014557Urostym EMG Cable, Ch 2CAB9062022-11-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08032248471030Securmeter Foley ManometerDELTA MED SPAFEN2025-05-19
10627825014844T-DOC 5Fr Air-Charged Abdominal Sensor CatheterLaborie Medical Technologies Corp.FEN2024-12-12
10627825014851T-DOC 5Fr Air-Charged Single Sensor CatheterLaborie Medical Technologies Corp.FEN2024-12-12
10627825014868T-DOC 5Fr Air-Charged Single Sensor CatheterLaborie Medical Technologies Corp.FEN2024-12-12
006278250005742-Way Stop CockLaborie Medical Technologies Canada ULCFEN2020-10-02
006278250005814-Way Stop CockLaborie Medical Technologies Canada ULCFEN2020-10-02
10627825010433Catheter, Pabd, Dual Lumen, Closed Balloon, Latex, 12FrLaborie Medical Technologies Canada ULCFEN2017-11-01
10627825010273Tubing, Infusion Pump for Laborie SystemsLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010280Tubing, Infusion Pump for MMS Solar SystemsLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010297Tubing, Infusion Pump for MMS Solar Systems, with spikesLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010303Tubing, Infusion Pump for MMS Solar Systems, with chamberLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010310Tubing, Infusion Pump for MMS Nexam NPU SystemsLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010327Tubing, Infusion Pump for Andromeda SystemsLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010334Tubing, Infusion Pump for Mediwatch SystemsLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010358Tubing, Extension Line, Clear, with Stopcock, 150 cmLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010365Tubing, Extension Line, Clear, 150 cmLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010372Tubing, Extension Line, Blue for Pves, 150 cmLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010389Tubing, Extension Line, Red for Pabd, 150 cmLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010396Tubing, Extension Line, Yellow for Pura, 150 cmLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010402Tubing, Extension Line, 2 Set, Blue/Red, 150 cmLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010419Tubing, Extension Line, 3 Set, Blue/Red/Yellow, 150 cmLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010426Pump Guard / Dampening chamberLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010440Catheter, Pabd, Dual Lumen, Closed Balloon, Silicone, 12FrLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010457Catheter, Pabd, Dual Lumen, Closed Balloon, Silicone, 9FrLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010464Catheter, Pabd, Single Lumen, Closed Balloon, Latex, 12FrLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010471Catheter, Pabd, Single Lumen, Closed Balloon, Silicone, 12FrLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010488Catheter, Pabd, Single Lumen, Split Balloon, PVC , Introducer 4.5FrLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010495Catheter, Pabd, Single Lumen, Split Balloon, PVC, 4.5FrLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010501Catheter, Pves & Vinf, Dual Lumen, 6FrLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010518Catheter, Pves & Vinf, Dual Lumen, 8FrLaborie Medical Technologies Canada ULCFEN2017-10-01