AccessGUDID - DEVICE: CNAP® Monitor 500 (09120073931436)

GUDID

Device Identifier (DI) Information

Brand Name: CNAP® Monitor 500
Version or Model: V1.5
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 21-FHCN-15536
Company Name: CNSystems Medizintechnik GmbH

Primary DI Number: 09120073931436
Issuing Agency: GS1
Commercial Distribution End Date: September 09, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 300526077 *Terms of Use

Device Description: SET of: 09120073930385, CNAP® Monitor 500, Main Unit including quick Guide 09120073930118, CNAP® controller set, incl. 09120073930101, CNAP® Controller and 09120073930088, Fixture for CNAP® controller, adapter between 09120073930101 CNAP® Controller and 09120073930354 CNAP® forearm fixing cuff 09120073930354, CNAP® forearm fixing cuff, for fixing 09120073930101 CNAP® Controller 09120073930095, 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 output 09120073930033, BP Wave Out: CNAP® transducer cable, Unit; grey; adapter to interface cable 09120073931344, 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 bracket NBP cuffs: 10840935102236, All Purpose Cuff, General, Large Adult, 98-0099-08, 20-FMA-15450 10840935102168, All Purpose Cuff, General, Adult 98-0097-10, 20-FMA-15350 10840935102113, All Purpose Cuff, General, Small Adult, 98-0095-09, 20-FMA-15250 10840935102052, All Purpose Cuff, 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, 2 pcs. Thermal paper, 20-HVZU-00258

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
36551	Patient monitoring system module, blood pressure, noninvasive	A small unit dedicated to the measurement of noninvasive blood pressure (indirect method) obtained through a standard sphygmomanometer cuff placed on the arm or leg. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the blood pressure parameter/information measured and provided by this module.	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 Atmospheric Pressure: between 15 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 15 and 95 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: d4f65011-90f6-4ae4-8363-2e3265abab20
Public Version Date: October 15, 2019
Public Version Number: 6
DI Record Publish Date: May 25, 2018