CNAP® Monitor 500 - SET of: 09120073930934, CNAP® Monitor 500, Main - CNSystems Medizintechnik AG

Duns Number:303562672

Device Description: SET of: 09120073930934, CNAP® Monitor 500, Main Unit including quick Guide09120073930767, SET of: 09120073930934, CNAP® Monitor 500, Main Unit including quick Guide09120073930767, CNAP® controller set, incl. 09120073930774 CNAP® Controller and 09120073930088 Fixture for CNAP® controller, adapter between 09120073930774 CNAP® Controller and 09120073930354 CNAP® forearm fixing cuff09120073930354, CNAP® forearm fixing cuff, for fixing 09120073930774 CNAP® Controller09120073930095, CNAP® cable, 2.5m; interface 09120073930774 CNAP® controller to 09120073930750 CNAP® Monitor 500 09120073930132, CNAP® double finger cuff "large", sensor with Maximum Lifecycle (300h)09120073930170, CNAP® double finger cuff "medium", sensor with Maximum Lifecycle (300h)09120073930200, CNAP® double finger cuff "small", sensor with Maximum Lifecycle (300h)09120073931030, AUX: Analog out connector, connector for data analog output09120073930033, BP Wave Out: CNAP® transducer cable, Unit; grey; adapter to interface cable09120073930293, Operator's Manual, 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

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More Product Details

Catalog Number

21-FHCN-15513

Brand Name

CNAP® Monitor 500

Version/Model Number

V1.4

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 21, 2017

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K082599

Product Code Details

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Device Record Status

Public Device Record Key

40892a77-93ce-4bab-b51e-1236170019a2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 28, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CNSYSTEMS MEDIZINTECHNIK AG" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 71