FDA.reportPublic FDA data

e∙Sense

Primary DI
08718122028339
Brand
e∙Sense
Company
PendraCare International B.V.
Model
Bladder & Urethral Dual Sensor Catheter, straight
Catalog number
37042005
Device description
e∙Sense Urodynamic catheters are single-use urodynamic pressure-sensing catheters and are intended to perform pressure measurement in the bladder, urethra, rectum or vagina.
Published
2016-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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
38718122028330PackageGS110In Commercial Distribution
08718122028339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3871812202833038718122028330
08718122028339087181220283398718122028339

GMDN Terms#

Term, Definition table
TermDefinition
Urodynamic catheterA long, thin, sterile, flexible or semi-rigid tube designed for connection to urodynamic measuring equipment for urodynamic examination of a patient. It is inserted into the bladder via the urethra or non-surgically via a stoma for cystometry, to drain the bladder to facilitate measurement of urinary output, and for urethral pressure and other urethral and voiding pressure examinations. It is available with various lumens (e.g., single, double, triple) providing one or more openings at the distal end, and is calibrated in increments to assist in positioning. It may be dedicated to a gas or water infusion technique. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length40Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight.
Special Storage Condition, Specify00keep dry
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Regulatory Flags#

DUNS number
413008652
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08718122024218Climber Guiding CatheterEBU3.75GC-P6EB370N2026-05-19
08718122013984Primum Guiding Catheter6F Primum JR4261028042026-02-02
08718122028896Primum Guiding Catheter6F Primum EBU3.5261088042026-02-02
08718122013915Primum Guiding Catheter6F Primum JL3.5261021042026-02-02
38718122013985Primum Guiding Catheter6F Primum JR4261028042026-02-02
38718122028897Primum Guiding Catheter6F Primum EBU3.5261088042026-02-02
08714729797876Convey5FConvey JL3H7493922866002016-05-01
08714729797883Convey5FConvey JL3.5H7493922866102016-05-01
08714729797890Convey5FConvey JL4H7493922866202016-05-01
08714729797906Convey5FConvey JL4.5H7493922866302016-05-01
08714729797913Convey5FConvey JL5H7493922866402016-05-01
08714729797920Convey5FConvey JL6H7493922866502016-05-01
08714729797937Convey5FConvey FL3H749392280502016-05-01
08714729797944Convey5FConvey FL3.5H749392280602016-05-01
08714729797951Convey5FConvey FL4H749392280702016-05-01
08714729797968Convey5FConvey FL4.5H749392280802016-05-01
08714729797975Convey5FConvey FL5H749392280902016-05-01
08714729797982Convey5FConvey FL6H749392281002016-05-01
08714729797999Convey5FConvey FCL3H7493922872502016-05-01
08714729798002Convey5FConvey FCL3.5H7493922827202016-05-01

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