AccessGUDID - DEVICE: GEMS Win Arrhythmia (00812324000204)

GUDID

Device Identifier (DI) Information

Brand Name: GEMS Win Arrhythmia
Version or Model: GW-ARR
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GW-ARR
Company Name: CardioComm Solutions, Inc

Primary DI Number: 00812324000204
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 251043907 *Terms of Use

Device Description: Global ECG Management System (GEMS) for Windows Arrhythmia

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?
34972	Cardiac mapping system computer	A dedicated computer with software that is a component of a cardiac mapping system and is used to process and store electronic information/data for the interpretation of cardiac physiological parameters received from the output of connected measuring devices [e.g., body surface or intracardiac electrocardiograph (ECG) sensors/transducers]. The measurements can be compared to pre-established diagnostic criteria for parameters such as cardiac blood flow, electrical conduction, or heart chamber geometry. The device may display real-time cardiac maps in various formats (e.g., electrical propagation maps, electrical potential maps, and cardiac chamber geometry maps).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DSH	Recorder, Magnetic Tape, Medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K022297	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: 2c633c41-f60e-4b59-ac2e-498ef30dab87
Public Version Date: November 17, 2023
Public Version Number: 1
DI Record Publish Date: November 09, 2023