AccessGUDID - DEVICE: CNAP® double finger cuff "medium" (09120073931658)

GUDID

Device Identifier (DI) Information

Brand Name: CNAP® double finger cuff "medium"
Version or Model: V4.4
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20-FVMA-15520I
Company Name: CNSystems Medizintechnik GmbH

Primary DI Number: 09120073931658
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 300526077 *Terms of Use

Device Description: Unit, with Infinity Lifecycle (1000h)

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?
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
Storage Environment Temperature: between 0 and 40 Degrees Celsius
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 15 and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 64.7 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6287f1b5-6ace-402f-9065-b9f662412170
Public Version Date: December 31, 2018
Public Version Number: 1
DI Record Publish Date: November 28, 2018