Home GUDID 00856362005012 iHealth
Primary DI 00856362005012
Brand iHealth
Company iHealth Labs Inc.
Model ECG3
Published 2019-02-10
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Unsafe 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 10856362005019 Package GS1 12 In Commercial Distribution 00856362005012 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10856362005019 10856362005019 00856362005012 00856362005012 856362005012 0856362005012
GMDN Terms# Term, Definition table Term Definition Electrocardiography telemetric monitoring system An assembly of devices designed to continuously measure and wirelessly transmit electrocardiographic (ECG) signals from a patient to a receiving location (e.g., central station, bedside monitor) for viewing. It typically consists of a portable transmitter with antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, as well as a receiver typically incorporated into a central station or bedside monitor that receives, consolidates, and displays the information. The system is typically used for ambulatory patients who require continuous monitoring (e.g., patients in step-down care areas).
Regulatory Flags# DUNS number 054953337 Device count 1 Lot or batch true Manufacturing date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08883000007413 AeviceMD AEVICE HEALTH PTE. LTD. DSH 2026-05-18 00857522005125 myPatch® DMS-SERVICE LLC DSH 2026-05-06 00884838129238 Care Assist Philips Medizin Systeme Böblingen GmbH DSH 2026-04-17 00884838129245 Care Assist Philips Medizin Systeme Böblingen GmbH DSH 2026-04-17 K00010 eWave 6-Lead EKG Wearlinq, Inc. DSH 2026-04-02 P00010 eWave Electrode Patch Wearlinq, Inc. DSH 2026-04-02 00884838129214 Care Assist Philips Medizin Systeme Böblingen GmbH DSH 2026-03-09 00884838129221 Care Assist Philips Medizin Systeme Böblingen GmbH DSH 2026-03-09 17540279200027 CardioSTAT Icentia Inc. DSH 2025-12-08 00884838127456 Care Assist Philips Medizin Systeme Böblingen GmbH DSH 2025-11-17 00884838127463 Care Assist Philips Medizin Systeme Böblingen GmbH DSH 2025-11-17 08800069700260 AT-Patch ATsens Co., Ltd. DSH 2025-11-05 08800069700277 AT-Patch ATsens Co., Ltd. DSH 2025-11-05 00884838127432 Care Assist Philips Medizin Systeme Böblingen GmbH DSH 2025-05-06 00884838127449 Care Assist Philips Medizin Systeme Böblingen GmbH DSH 2025-05-06 27540279250029 CardioSTAT Icentia Inc. DSH 2024-12-18 27540279250074 CardioSTAT Icentia Inc. DSH 2024-12-18 27540279250142 CardioSTAT Icentia Inc. DSH 2024-12-18 00884838123717 Care Assist Philips Medical Systems Hsg DSH 2024-11-27 00884838123724 Care Assist Philips Medical Systems Hsg DSH 2024-11-27 00860007323409 Vitals360 Vocare, Inc. DSH 2024-09-10 B146EP25R0 ePatch Sensor 2.5, Rebuilt BRAEMAR MANUFACTURING, LLC DSH 2024-06-26 04250413405640 ABPM pro basic device SOMNOmedics AG 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