FDA.reportPublic FDA data

ATMOS Air-Charged Pressure Sensor

Primary DI
08594211570824
Brand
ATMOS Air-Charged Pressure Sensor
Company
MEDKONSULT medical technology s.r.o.
Model
PS11-21A05
Device description
Air-Charged Pressure Sensor intended for measurement of urodynamic pressures transmitted by approved types of measuring, air-filled catheters in a set of specified urodynamic measurement systems, abdominal 0.5m for MMS
Published
2024-11-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08594211570824PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08594211570824085942115708248594211570824

GMDN Terms#

Term, Definition table
TermDefinition
Air/gas pressure transducerA noninvasive electronic device designed to convert air or gas pressure signals into electrical signals for subsequent display or processing by a parent device (e.g., physiological data recorder, gastrointestinal motility analysis system). It may be a compact unit or included in an electrical cable, and receives pressure signals from connected pressure-measuring devices (e.g., urodynamic air-charged catheter, monitoring respiratory tubing).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
361814147
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08594211570466ATMOS Air-Charged Pressure SensorPS11-01A252024-11-06
08594211570473ATMOS Air-Charged Pressure SensorPS11-01R252024-11-06
08594211570480ATMOS Air-Charged Pressure SensorPS11-01U252024-11-06
08594211570497ATMOS Air-Charged Pressure SensorPS11-01V252024-11-06
08594211570541ATMOS Air-Charged Pressure SensorPS11-02A052024-11-06
08594211570558ATMOS Air-Charged Pressure SensorPS11-02R052024-11-06
08594211570565ATMOS Air-Charged Pressure SensorPS11-02U052024-11-06
08594211570572ATMOS Air-Charged Pressure SensorPS11-02V052024-11-06
08594211570664ATMOS Air-Charged Pressure SensorPS11-11A052024-11-06
08594211570671ATMOS Air-Charged Pressure SensorPS11-11A252024-11-06
08594211570688ATMOS Air-Charged Pressure SensorPS11-11R052024-11-06
08594211570695ATMOS Air-Charged Pressure SensorPS11-11R252024-11-06
08594211570701ATMOS Air-Charged Pressure SensorPS11-11U052024-11-06
08594211570718ATMOS Air-Charged Pressure SensorPS11-11U252024-11-06
08594211570725ATMOS Air-Charged Pressure SensorPS11-11V052024-11-06
08594211570732ATMOS Air-Charged Pressure SensorPS11-11V252024-11-06
08594211570831ATMOS Air-Charged Pressure SensorPS11-21A252024-11-06
08594211570848ATMOS Air-Charged Pressure SensorPS11-21R052024-11-06
08594211570855ATMOS Air-Charged Pressure SensorPS11-21R252024-11-06
08594211570862ATMOS Air-Charged Pressure SensorPS11-21U052024-11-06

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