AccessGUDID - DEVICE: DeepRhythm Platform (05903021560698)

GUDID

Device Identifier (DI) Information

Brand Name: DeepRhythm Platform
Version or Model: DeepRhythm Platform
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDICALGORITHMICS S A

Primary DI Number: 05903021560698
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 522657576 *Terms of Use

Device Description: The DeepRhythm Platform is a modern cloud-based software system with microservice architecture and a browser-based user interface. It provides a comprehensive arrhythmia diagnosis process and monitoring session management capabilities, which consist of: • enrolling a patient for an ECG monitoring session in a medical facility, • receiving the signal from a compatible monitoring device worn by the patient, • using an external AI service for signal analysis and classification, • processing signal and annotations received from the external AI service, including statistics computation, • reviewing the signal and annotations by an ECG Technician, • generating and publishing reports for single ECG episodes and the entire monitoring session as well, • reviewing published reports back at the medical facility that ordered the monitoring session in the first place.

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?
41651	Electrocardiographic long-term ambulatory recording analyser application software	A dedicated application data program designed for use in, or together with, an electrocardiographic long-term ambulatory recording analyser so that this may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DPS	Electrocardiograph
DQK	Computer, Diagnostic, Programmable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K232161	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: 75f8c4e3-1c3b-40ae-8ca1-955f6e15b77b
Public Version Date: December 30, 2024
Public Version Number: 1
DI Record Publish Date: December 20, 2024