FDA.reportPublic FDA data

Epatch 2.0

Primary DI
B146EP2010
Brand
Epatch 2.0
Company
BRAEMAR MANUFACTURING, LLC
Model
02-01575
Published
2019-10-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DSHRecorder, Magnetic Tape, Medical
DSIDetector And Alarm, Arrhythmia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSHRecorder, Magnetic Tape, MedicalCardiovascular2
DSIDetector And Alarm, ArrhythmiaCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171410000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171410000ePatchBraemar Manufacturing, LLC2018-01-04DSH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B146EP2010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic ambulatory recorderAn 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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
049529118
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838128729C6 Monitor A13, Verizon02-023862025-10-06
00884838128736C6 Monitor A13, T Mobile02-023872025-10-06
B146C6R30C6 Sensor 3.0, Rebuilt02-021242024-06-26
B146EP25R0ePatch Sensor 2.5, Rebuilt02-022512024-06-26
B146C6M20C6 Monitor UGW100-0048-022019-10-08
B146EP2510ePatch 2.5, BTH02-020452023-01-20
B146EP2520ePatch 2.5, BTI02-020462023-11-22
B146C6M60C6 Monitor A10e, Sprint02-018002023-06-15
B146C6M80C6 Monitor A13, T Mobile02-021192023-06-15
B146C6M90C6 Monitor A13, Verizon02-021182023-06-15
B146EP2R10ePatch 2.0 rebuilt02-019972022-07-13
B146C6M70C6 Monitor A10e, Verizon02-018042022-03-21
B146C6E10C6 Sensor 3.002-018462021-04-28
B146C6R10C6 Sensor 2.5 rebuilt02-018892021-03-30
B146C6R20C6 Sensor 2.0 rebuilt02-018972021-03-30
B146BTPM0BTP-1000S Monitor100-0045-022020-07-15
B146C6M40C6 Monitor02-015492020-07-15
B146EP2020ePatch 2.0 BTI02-016502020-07-15
B146C6D0C6 Sensor D02-015612019-10-08
B146C6D10C6 Sensor 02-016062019-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20884838119769Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHDSI2026-05-19
20884838119776Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHDSI2026-05-19
08883000007413AeviceMDAEVICE HEALTH PTE. LTD.DSH2026-05-18
00857522005125myPatch®DMS-SERVICE LLCDSH2026-05-06
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyDSI2026-04-15
K00010eWave 6-Lead EKGWearlinq, Inc.DSH2026-04-02
P00010eWave Electrode PatchWearlinq, Inc.DSH2026-04-02
00195278343383CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DSI2026-02-11
00195278343512CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DSI2026-02-11
00884838127456Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2025-11-17
08800069700260AT-PatchATsens Co., Ltd.DSH2025-11-05
08800069700277AT-PatchATsens Co., Ltd.DSH2025-11-05
00884838127432Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2025-05-06
00884838127432Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2025-05-06
00884838127449Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2025-05-06
00884838127449Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2025-05-06
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.DSI2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.DSI2024-12-19
00884838123717Care AssistPhilips Medical Systems HsgDSH2024-11-27
00884838123717Care AssistPhilips Medical Systems HsgDSI2024-11-27
00884838123724Care AssistPhilips Medical Systems HsgDSH2024-11-27
00884838123724Care AssistPhilips Medical Systems HsgDSI2024-11-27
00860007323409Vitals360Vocare, Inc.DSH2024-09-10
00850043907046Zio ECG Utilization Software (ZEUS) SystemIRHYTHM TECHNOLOGIES, INC.DSI2024-07-26
00850033167146Total VitalsGlobalmed Holdings, LLCDSH2023-12-08
00850033167153Total VitalsGlobalmed Holdings, LLCDSH2023-12-08
00850033167160Total VitalsGlobalmed Holdings, LLCDSH2023-12-08
00763000613747LINQ II™MEDTRONIC, INC.DSI2023-11-19
00855778005456uCor Heart Failure and Arrhythmia Management SystemZOLL MANUFACTURING CORPORATIONDSI2023-06-22
10841522129797TruLinkSPACELABS HEALTHCARE (WASHINGTON), INCDSI2023-05-16