FDA.reportPublic FDA data

Bladder filling Catheter

Primary DI
10627825007181
Brand
Bladder filling Catheter
Company
Laborie Medical Technologies Canada ULC
Model
9021P5230
Device description
10F
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
10627825007181PackageGS110In Commercial Distribution
00627825007177PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1062782500718110627825007181
00627825007177006278250071776278250071770627825007177

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.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
203383526
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30627825007024Extension Set 29021P12832016-09-21
20627825007294Extension Line, 60 cm9021P63122016-09-21
20627825007317Extension Line, 1500mm9021P63322016-09-21
20627825007324Extension Line, 15cm9021P63512016-09-21
20627825007348Extension Line, 150cm Blue9021P63712016-09-21
30627825007352Extension Line, 150cm Yellow9021P63812016-09-21
20627825007034Extension Set 39021P12932016-09-21
30627825007307Extension Line, 90 cm9021P63222016-09-21
20627825007331Extension Line, 150cm Red9021P63612016-09-21
20627825010355Tubing, Extension Line, Clear, with Stopcock, 150 cmTUBEX1CS2017-10-01
20627825010362Tubing, Extension Line, Clear, 150 cmTUBEX1C2017-10-01
20627825010379Tubing, Extension Line, Blue for Pves, 150 cmTUBEX1B2017-10-01
20627825010386Tubing, Extension Line, Red for Pabd, 150 cmTUBEX1R2017-10-01
30627825010390Tubing, Extension Line, Yellow for Pura, 150 cmTUBEX1Y2017-10-01
30627825010406Tubing, Extension Line, 2 Set, Blue/Red, 150 cmTUBEX2BR2017-10-01
20627825010416Tubing, Extension Line, 3 Set, Blue/Red/Yellow, 150 cmTUBEX3BRY2017-10-01
00627825011624NXT Go Urodynamics SystemNXT21002021-08-04
00627825011761PIM NXT for FluidPIX22312021-08-04
00627825011778UPP Puller NXTUPX20012021-08-04
00627825011785NXT Go Infusion HookMSM11852021-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
38032248471031Securmeter Foley ManometerDELTA MED SPAFEN2025-05-19
08720648846069PIM NXT for eSenseLaborie Medical Technologies Corp.FEN2025-02-21
00627825013529e•Sense 7Fr Single Sensor Bladder CatheterLaborie Medical Technologies Corp.FEN2024-12-12
10627825013533e•Sense 7Fr Single Sensor Coudé Bladder CatheterLaborie Medical Technologies Corp.FEN2024-12-12
10627825013540e•Sense 7Fr Dual Sensor Urethral CatheterLaborie Medical Technologies Corp.FEN2024-12-12
00627825013550e•Sense 7Fr Dual Sensor Coudé Uretheral CatheterLaborie Medical Technologies Corp.FEN2024-12-12
00627825013567e•Sense 7Fr Abdominal CatheterLaborie Medical Technologies Corp.FEN2024-12-12
20627825014841T-DOC 5Fr Air-Charged Abdominal Sensor CatheterLaborie Medical Technologies Corp.FEN2024-12-12
20627825014858T-DOC 5Fr Air-Charged Single Sensor CatheterLaborie Medical Technologies Corp.FEN2024-12-12
20627825014865T-DOC 5Fr Air-Charged Single Sensor CatheterLaborie Medical Technologies Corp.FEN2024-12-12
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08594211570671ATMOS Air-Charged Pressure SensorMEDKONSULT medical technology s.r.o.FEN2024-11-06
08594211570688ATMOS Air-Charged Pressure SensorMEDKONSULT medical technology s.r.o.FEN2024-11-06
08594211570695ATMOS Air-Charged Pressure SensorMEDKONSULT medical technology s.r.o.FEN2024-11-06
08594211570701ATMOS Air-Charged Pressure SensorMEDKONSULT medical technology s.r.o.FEN2024-11-06
08594211570718ATMOS Air-Charged Pressure SensorMEDKONSULT medical technology s.r.o.FEN2024-11-06
08594211570725ATMOS Air-Charged Pressure SensorMEDKONSULT medical technology s.r.o.FEN2024-11-06
08594211570732ATMOS Air-Charged Pressure SensorMEDKONSULT medical technology s.r.o.FEN2024-11-06
08594211570824ATMOS Air-Charged Pressure SensorMEDKONSULT medical technology s.r.o.FEN2024-11-06
08594211570831ATMOS Air-Charged Pressure SensorMEDKONSULT medical technology s.r.o.FEN2024-11-06
08594211570848ATMOS Air-Charged Pressure SensorMEDKONSULT medical technology s.r.o.FEN2024-11-06
08594211570855ATMOS Air-Charged Pressure SensorMEDKONSULT medical technology s.r.o.FEN2024-11-06