Home GUDID 27540279250029 CardioSTAT
Primary DI 27540279250029
Brand CardioSTAT
Company Icentia Inc.
Model 10-006
Device description CardioSTAT Installation Kit - ECG Recorder 2D Test.
Published 2024-12-18
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name DSH Recorder, Magnetic Tape, Medical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DSH Recorder, Magnetic Tape, Medical Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 27540279250029 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 27540279250029 27540279250029
GMDN Terms# Term, Definition table Term Definition Electrocardiographic ambulatory recorder An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).
Regulatory Flags# DUNS number 241983607 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 17540279200027 CardioSTAT Icentia Inc. DSH 2025-12-08 27540279250074 CardioSTAT Icentia Inc. DSH 2024-12-18 27540279250142 CardioSTAT Icentia Inc. DSH 2024-12-18 B146EP25R0 ePatch Sensor 2.5, Rebuilt BRAEMAR MANUFACTURING, LLC DSH 2024-06-26 04250413405640 ABPM pro basic device SOMNOmedics GmbH DSH 2024-05-08 00815187020112 Matrix Wearable GLOBAL INSTRUMENTATION, LLC DSH 2024-04-01 00815187020440 Matrix Wearable GLOBAL INSTRUMENTATION, LLC DSH 2024-04-01 00815187020457 Matrix Wearable GLOBAL INSTRUMENTATION, LLC DSH 2024-04-01 00815187020587 Matrix Wearable GLOBAL INSTRUMENTATION, LLC DSH 2024-04-01 00815187020594 Matrix Wearable GLOBAL INSTRUMENTATION, LLC DSH 2024-04-01 17540279105018 EART Icentia Inc. DSH 2024-03-26 17540279200072 CardioSTAT Icentia Inc. DSH 2024-03-26 17540279200140 CardioSTAT Icentia Inc. DSH 2024-03-26 B322H0011 LD-EKG LD TECHNOLOGY, LLC DSH 2024-03-05 06944413820463 Holter ECG and ABP System Edan Instruments, Inc. DSH 2023-11-30 06944413820470 Holter ECG and ABP System Edan Instruments, Inc. DSH 2023-11-30 06944413820487 Holter ECG and ABP System Edan Instruments, Inc. DSH 2023-11-30 06944413820494 Holter ECG and ABP System Edan Instruments, Inc. DSH 2023-11-30 06944413820500 Holter ECG and ABP System Edan Instruments, Inc. DSH 2023-11-30 B146EP2520 ePatch 2.5, BTI BRAEMAR MANUFACTURING, LLC DSH 2023-11-22 00812324000204 GEMS Win Arrhythmia CardioComm Solutions, Inc DSH 2023-11-09 00812324000211 GEMS Win TTM CardioComm Solutions, Inc DSH 2023-11-09 00812324000242 GEMS Win AutoAttendant CardioComm Solutions, Inc DSH 2023-11-09 00812324000259 GEMS Win Air CardioComm Solutions, Inc DSH 2023-11-09 00812324000228 GEMS Win TTM & ICD CardioComm Solutions, Inc DSH 2023-11-08 00812324000266 GEMS Win HL7 CardioComm Solutions, Inc DSH 2023-11-08 08800159500015 S-Patch Ex Wellysis Corp. DSH 2023-11-08 B146EP2510 ePatch 2.5, BTH BRAEMAR MANUFACTURING, LLC DSH 2023-01-20 18800069700175 AT-Patch ATsens Co., Ltd. DSH 2022-12-23 00850043625001 Strados Labs Strados Labs, Inc. DSH 2022-12-02