AccessGUDID - DEVICE: Cardiospy ECG Holter System (05999883490075)

GUDID

Device Identifier (DI) Information

Brand Name: Cardiospy ECG Holter System
Version or Model: USB-02 Dongle
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DEV-00USB-02
Company Name: LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság

Primary DI Number: 05999883490075
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 520963286 *Terms of Use

Device Description: The USB-02 Dongle is the hardware key for Cardiospy software that makes possible the use of Cardiospy ECG Holter recorders (EC-2H, EC-3H or EC-12H) as a system and the management, procession and evaluation of the recorded row data. The universal analysis SW provides full disclosure ECG recordings on channels with a precise automatic QRS and PM detection, template and rhythm analysis, QRS classification, efficient ST, QT, AF, PM, HRV time and frequency based analysis with color coded display and printing with interactive modification possibilities in the automatic analysis in several languages. Export-import and archiving option of the recordings is available. The evaluation software works with a conventional PC- based computer under Win 2000/XP/VISTA , Windows 7, Windows 8, Windows 10 operating systems. The connection between the Holter and computer is performed by using Bluetooth and USB dongle. The Cardiospy analysis software provides ECG records of excellent quality.

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?
36827	Electrocardiographic long-term ambulatory recording analyser	An electronic device intended to be used for the analysis of long-term (often 24-hours) heart activity data, which has previously been registered by an electrocardiographic long-term ambulatory recorder (Holter), to which the patient was connected and carried upon his or her person.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MLO	Electrocardiograph, Ambulatory, With Analysis Algorithm

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140847	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
Weight: 50 Gram
Width: 18.5 Millimeter
Width: 53 Millimeter
Length: 67.5 Millimeter

Device Record Status

Public Device Record Key: d03587e9-3fb5-4952-ba54-80857796d7c4
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 06, 2017