CNSystems Medizintechnik GmbH

Address:REININGHAUSSTRASSE 13,Graz Steiermark,AT

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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 SET of: 09120073930385, CNAP® Monitor 500, Main Unit including quick Guide09120073930118, CNAP® controller set, incl. 09120073930101, CNAP® Controller and 09120073930088, Fixture for CNAP® controller, adapter between 09120073930101 CNAP® Controller and 09120073930354 CNAP® forearm fixing cuff09120073930354, CNAP® forearm fixing cuff, for fixing 09120073930101 CNAP® Controller09120073930095, CNAP® cable, 2.5m; interface 09120073930101 CNAP® controller to 09120073930385 CNAP® Monitor 500 09120073930125, CNAP® double finger cuff "large", sensor with Extended Lifecycle (150h)09120073930163, CNAP® double finger cuff "medium", sensor with Extended Lifecycle (150h)09120073930200, CNAP® double finger cuff "small", sensor with Extended Lifecycle (150h)09120073931368, AUX: Analog out connector, connector for data analog output09120073930033, BP Wave Out: CNAP® transducer cable, Unit; grey; adapter to interface cable09120073931344, Operator's Manual USA, 09120073930668, CNAP® Component Organizer Set for CNAP® Monitor, 09120073930798 CNAP® double finger cuff mounting bracket together with 09120073930781 CNAP® controller mounting bracketNBP cuffs:10840935102236, All Purpose Cuff, General, Large Adult, 98-0099-08, 20-FMA-1545010840935102168, All Purpose Cuff, General, Adult 98-0097-10, 20-FMA-1535010840935102113, All Purpose Cuff, General, Small Adult, 98-0095-09, 20-FMA-1525010840935102052, All Purpose Cuff, General, Child, 98-0093-06, 20-FMA-15150Patient Hose, 3 Meter, Rectus Fittings, 98-0028-00, 20-FMA-05050Power cord USA Standard, 20-HEKA-01017, primary cord to external mains adapter External mains adapter, Manufacturer: M+R Multitronik GmbH, Niels-Bohr-Ring 28, 23568 Lübeck, Germany, phone: +49 451 60 99 5 0,2 pcs. Thermal paper, 20-HVZU-00258

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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