AccessGUDID - DEVICE: CNAP® Monitor 500 at (09120073930743)

GUDID

Device Identifier (DI) Information

Brand Name: CNAP® Monitor 500 at
Version or Model: V1.4
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 21-FHCN-15500
Company Name: CNSystems Medizintechnik AG

Primary DI Number: 09120073930743
Issuing Agency: GS1
Commercial Distribution End Date: November 19, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 303562672 *Terms of Use

Device Description: SET of: 09120073930750, CNAP® Monitor 500, Main Unit including quick Guide 09120073930767, CNAP® controller set, incl. 09120073930774 CNAP® Controller and 09120073930088 Fixture for CNAP® controller, adapter between 09120073930774 CNAP® Controller and 09120073930354 CNAP® forearm fixing cuff 09120073930354, CNAP® forearm fixing cuff, for fixing 09120073930774 CNAP® Controller 09120073930095, CNAP® cable, 2.5m; interface 09120073930774 CNAP® controller to 09120073930750 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) 09120073930026, AUX: Analog out connector, connector for data analog output 09120073930033, BP Wave Out: CNAP® transducer cable, Unit; grey; adapter to interface cable 09120073930293, Operator's Manual, 09120073930668, CNAP® Component Organizer Set for CNAP® Monitor, 09120073930798 CNAP® double finger cuff mounting bracket together with 09120073930781 CNAP® controller mounting bracket NBP cuffs: 10840935102236, All Purpose, General, Large Adult, 98-0099-08, 20-FMA-15450 10840935102168, All Purpose, General, Adult 98-0097-10, 20-FMA-15350 10840935102113, All Purpose, General, Small Adult, 98-0095-09, 20-FMA-15250 10840935102052, All Purpose, General, Child, 98-0093-06, 20-FMA-15150 Patient Hose, 3 Meter, Rectus Fittings, 98-0028-00, 20-FMA-05050 Power 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 Thermal paper, 20-HVZU-00258

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61237	Noninvasive haemodynamic monitoring system	An assembly of mains electricity (AC-powered) devices intended to be used for the noninvasive continuous measurement of arterial blood pressure, cardiac output, and other haemodynamic variables by automated radial arterial tonometry. It consists of a bracelet-like detection device worn on the wrist and an attached monitor with user interface. It is typically used in the operating arena or the intensive care unit (ICU).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXN	System, Measurement, Blood-Pressure, Non-Invasive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K082599	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Atmospheric Pressure: between 64.7 and 106 KiloPascal
Handling Environment Humidity: between 15 and 85 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 590205a3-2216-4c34-acc3-5f4e471fdcd1
Public Version Date: November 20, 2019
Public Version Number: 4
DI Record Publish Date: October 25, 2016