CNSystems Medizintechnik GmbH

Address:REININGHAUSSTRASSE 13,Graz Steiermark,AT

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Measurement, Blood-Pressure, Non-Invasive (DXN) (10)

Premarket Exempt

Clear

CNAP® Monitor 500 - 09120073931436 Catalog Number : 21-FHCN-15536

Device Description : SET of: 09120073930385, CNAP® Monitor 500, Main Unit including quick Guide091200

Device Class : 2

Duns Number: 300526077

Premarket Exempt : No

Product Code : DXN

Prescription Use : Yes

Device Count : 1

AUX: Analog Out connector - 09120073931474 Catalog Number : 20-FEKA-01100

Device Description : Unit; connector for data analog output

Device Class : 2

Duns Number: 300526077

Premarket Exempt : No

Product Code : DXN

Prescription Use : Yes

Device Count : 1

BP Wave Out: CNAP® transducer cable - 09120073931481 Catalog Number : 20-FFKA-01200

Device Description : Unit; grey; adapter to interface cable

Device Class : 2

Duns Number: 300526077

Premarket Exempt : No

Product Code : DXN

Prescription Use : Yes

Device Count : 1

BP Wave Out: CNAP® transducer cable - 09120073931498 Catalog Number : 20-FFKA-01203

Device Description : Unit; yellow; adapter to interface cable

Device Class : 2

Duns Number: 300526077

Premarket Exempt : No

Product Code : DXN

Prescription Use : Yes

Device Count : 1

BP Wave Out: CNAP® transducer cable - 09120073931504 Catalog Number : 20-FFKA-01201

Device Description : Unit; black; adapter to interface cable

Device Class : 2

Duns Number: 300526077

Premarket Exempt : No

Product Code : DXN

Prescription Use : Yes

Device Count : 1

BP Wave Out: CNAP® transducer cable - 09120073931511 Catalog Number : 20-FFKA-01202

Device Description : Unit; red; adapter to interface cable

Device Class : 2

Duns Number: 300526077

Premarket Exempt : No

Product Code : DXN

Prescription Use : Yes

Device Count : 1

CNAP® cable - 09120073931528 Catalog Number : 20-FEKA-10041

Device Description : Unit; 2.5m; Primary DI Number valid for all versions of the cable

Device Class : 2

Duns Number: 300526077

Premarket Exempt : No

Product Code : DXN

Prescription Use : Yes

Device Count : 1

CNAP® controller - 09120073931535 Catalog Number : 21-FHCN-16706

Device Description : Unit;

Device Class : 2

Duns Number: 300526077

Premarket Exempt : No

Product Code : DXN

Prescription Use : Yes

Device Count : 1

CNAP® controller organizer - 09120073931542 Catalog Number : 21-FHSG-02002

Device Description : Unit; for storage of CNAP® controller

Device Class : 2

Duns Number: 300526077

Premarket Exempt : No

Product Code : DXN

Prescription Use : Yes

Device Count : 1

CNAP® double finger cuff "large" - 09120073931559 Catalog Number : 20-FVMA-15620E

Device Description : Unit; sensor with Extended Lifecycle (150h)

Device Class : 2

Duns Number: 300526077

Premarket Exempt : No

Product Code : DXN

Prescription Use : Yes

Device Count : 1

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