FDA.reportPublic FDA data

PIM NXT for eSense

Primary DI
08720648846069
Brand
PIM NXT for eSense
Company
Laborie Medical Technologies Corp.
Model
PIX7000
Published
2025-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
08720648846069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720648846069087206488460698720648846069

GMDN Terms#

Term, Definition table
TermDefinition
Urodynamic measurement systemAn assembly of devices used for advanced diagnosis/study of the bladder. It is used to identify the cause of abnormal voiding, including incontinence and is useful for the diagnosis of, e.g., neurogenic bladder diseases, stress incontinence, urinary path obstruction or spastic sphincters. A diagnostic urodynamic evaluation consists of uroflowmetry (measurement of urinary flow rate), urethral pressure profilometry (measurement of urethral pressure), gas or water cystometry (measurement of bladder capacity and response), and electromyogram (EMG) recording (the measurement of sphincter and other muscle activity). Long-term recording may also be analysed.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117783313
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing 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
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
00627825013550e•Sense 7Fr Dual Sensor Coudé Uretheral CatheterCATEB37C2024-12-12
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