CNAP® Monitor 500 - SET of: 09120073930385, CNAP® Monitor 500, Main - CNSystems Medizintechnik GmbH

Duns Number:300526077

Device Description: SET of: 09120073930385, CNAP® Monitor 500, Main Unit including quick Guide09120073930118, 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

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More Product Details

Catalog Number

21-FHCN-15536

Brand Name

CNAP® Monitor 500

Version/Model Number

V1.5

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 09, 2019

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

d4f65011-90f6-4ae4-8363-2e3265abab20

Public Version Date

October 15, 2019

Public Version Number

6

DI Record Publish Date

May 25, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CNSYSTEMS MEDIZINTECHNIK GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 60