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
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
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
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 60 |