FDA.reportPublic FDA data

MicroER

Primary DI
00850725007057
Brand
MicroER
Company
Lifewatch
Model
MicroER
Device description
Personal Electrocardiogram (ECG) Transmitter
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXHTransmitters And Receivers, Electrocardiograph, Telephone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXHTransmitters And Receivers, Electrocardiograph, TelephoneCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K963725000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K963725000MODEL CG-2206 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE (MODIFIED)Card Guard , Ltd.1997-09-10DXH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850725007057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850725007057008507250070578507250070570850725007057

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiography telemetric monitoring system transmitterA body-worn, battery-powered component of an electrocardiography telemetric monitoring system designed to continuously measure and wirelessly transmit real-time electrocardiographic (ECG) signals [and sometimes additional parameters such as heart rate, skin temperature, or haemoglobin oxygen saturation (SpO2)] to a remote receiver (e.g., central station server); it may in addition record/analyse data during a period of time for later retrieval (Holter reporting). The transmitter typically includes an antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, and may be provided with dedicated data management/communication software. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-700-3788DL-CCCSupervisors@lifewatch.com

Regulatory Flags#

DUNS number
797936734
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850725007002LifeWatch Mobile Cardiac Telemetry 3-LeadMCT 3L- Ozone-Verizon2016-09-16
00850725007019LifeWatch Mobile Cardiac Telemetry 3-LeadMCT 3L-ES400-Verizon2016-09-16
00850725007026LifeWatch Mobile Cardiac Telemetry 3-LeadMCT 3L-Brigadier-Verizon2016-09-16
00850725007033LifeWatch Mobile Cardiac Telemetry 3-LeadMCT 3L-Universal Gateway-Verizon2016-09-16
00850725007040LifeWatch Mobile Cardiac Telemetry 1 Lead PatchMCT 1L Patch-Universal Gateway-Verizon2016-09-16
00850725007064ExplorerExplorer2016-09-16
00850725007071King of Hearts AFKing of Hearts AF2016-09-16
00850725007088Lifestar AF ExpressLifestar AF Express2016-09-16
00850725007095LifeWatch Mobile Cardiac Telemetry 3-LeadMCT 3L-ES400-ATT2016-09-16
00850725007101LifeWatch Mobile Cardiac Telemetry 3-LeadMCT 3L-International2016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05419980589309FibriCheckQompiumDXH2026-05-06
05419980589316FibriCheckQompiumDXH2026-05-06
05419980589323FibriCheckQompiumDXH2026-05-06
05419980589347FibriCheckQompiumDXH2026-05-06
00195278343512CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DXH2026-02-11
00198953107263MACGe Medical Systems Information Technologies, Inc.DXH2026-01-27
07290008960380SmartheartSHL TELEMEDICINE INTERNATIONAL LTD.DXH2025-12-09
04719872981756QT ECGQt Medical, Inc.DXH2025-05-12
B353UB22511UbiqVue HolterLifesignals, Inc.DXH2025-04-22
B353UA2251R1UbiqVue Lifesignals, Inc.DXH2025-04-22
00195278421456CAMGE Medical Systems Information Technologies, Inc.DXH2025-04-07
00812324000297GEMS Mobile ECGCardioComm Solutions, IncDXH2025-03-20
B210AC0290K1000Alivecor, Inc.DXH2025-03-18
00840682144322MACGE Medical Systems Information Technologies, Inc.DXH2025-03-13
00860006382308SENSINEL™ CPM REPLACEMENT ADHESIVE PADAnalog Devices, Inc.DXH2025-03-13
00860006382315SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DXH2025-03-13
00860006382322SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DXH2025-03-13
00860006382339SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.DXH2025-03-13
00860006382346SENSINEL™ CPM ALIGNMENT TOOLAnalog Devices, Inc.DXH2025-03-13
20860006382302SENSINEL™ CPM REPLACEMENT ADHESIVES (15 Pack)Analog Devices, Inc.DXH2025-03-13
08908013617128Frontier X PlusFOURTH FRONTIER TECHNOLOGIES PRIVATE LIMITEDDXH2025-02-07
00850043907046Zio ECG Utilization Software (ZEUS) SystemIRHYTHM TECHNOLOGIES, INC.DXH2024-07-26
04719872981527QT ECGQt Medical, Inc.DXH2024-07-08
04719872981534QT ECGQt Medical, Inc.DXH2024-07-08
00856298006428EZLink-RSCOTTCARE CORPORATION, THEDXH2024-05-23
00856298006435EZLink-CSCOTTCARE CORPORATION, THEDXH2024-05-23
B210AC0110KardiaBand SystemAlivecor, Inc.DXH2024-03-22
03700546708275Withings®WITHINGSDXH2023-09-07
03700546708435Withings®WITHINGSDXH2023-08-30
03700546708442Withings®WITHINGSDXH2023-08-30