AccessGUDID - DEVICE: Set of electrodes (09120073930460)

GUDID

Device Identifier (DI) Information

Brand Name: Set of electrodes
Version or Model: V1.0
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 01616
Company Name: CNSystems Medizintechnik AG

Primary DI Number: 09120073930460
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 4ECG electrodes, 3 ICG electrodes and one grounding pad

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:	Yes
Prescription Use (Rx):	No
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 [?]
K014063	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d0a553fc-5fe8-490d-b38d-b4b4be4e9f03
Public Version Date: November 20, 2019
Public Version Number: 4
DI Record Publish Date: October 27, 2016