FDA.reportPublic FDA data

ATMOS Air-Charged Pressure Sensor

Primary DI
08594211570497
Brand
ATMOS Air-Charged Pressure Sensor
Company
MEDKONSULT medical technology s.r.o.
Model
PS11-01V25
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, vesical 2.5m
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
08594211570497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08594211570497085942115704978594211570497

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
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
08594211570824ATMOS Air-Charged Pressure SensorPS11-21A052024-11-06
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

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