FDA.reportPublic FDA data

CATHETER POUR CYSTOMETRIE 2 VOIES CH 6

Primary DI
03665039002417
Brand
CATHETER POUR CYSTOMETRIE 2 VOIES CH 6
Company
PRINCE MEDICAL
Model
VS1480640
Catalog number
VS1480640
Published
2021-10-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

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
03665039010832PackageGS150In Commercial Distribution
03665039002417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03665039010832036650390108323665039010832
03665039002417036650390024173665039002417

GMDN Terms#

Term, Definition table
TermDefinition
Urodynamic manometric catheter, non-electronicA sterile, non-electrical, long flexible tube intended to be inserted into the bladder via the urethra, or a stoma, for measuring urethral/bladder pressure, urinary output, other urethral and voiding pressures, and/or cystometry. The measuring method employed is typically the infusion of water (water-perfused catheter) or insufflation of air/gas (air-charged catheter) into the catheter, whereby pressure signals are conducted to proximally-connected external pressure transducers in urodynamic examination equipment. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
0344265476clement.gallois@omerin.com

Regulatory Flags#

DUNS number
569442924
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03665039001656Endoline VIPERSN3980718SN39807182024-01-30
03665039001663Endoline PUNCSN4000718SN40007182024-01-30
03665039005630Extraction Kit B-4815B-48152024-01-30
03665039010832CATHETER POUR CYSTOMETRIE 2 VOIES CH 6VS1480640VS14806402021-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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