FDA.reportPublic FDA data

myPatch®

Primary DI
00857522005019
Brand
myPatch®
Company
DMS-SERVICE LLC
Model
s
Catalog number
mp3
Device description
3 channel Holter recorder
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSHRECORDER, MAGNETIC TAPE, MEDICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSHRecorder, Magnetic Tape, MedicalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160704000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160704000myPatch-sDms-Service, LLC2016-07-15DSH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857522005019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857522005019008575220050198575220050190857522005019

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).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth10Millimeter
Length40Millimeter
Width49Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)407-2824sales@dms-service.com

Regulatory Flags#

DUNS number
824740059
Device count
1
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857522005125myPatch®slmp3sl2026-05-06
00857522005095myPatch®3 channelmpE3s2016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08883000007413AeviceMDAEVICE HEALTH PTE. LTD.DSH2026-05-18
00857522005125myPatch®DMS-SERVICE LLCDSH2026-05-06
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2026-04-17
K00010eWave 6-Lead EKGWearlinq, Inc.DSH2026-04-02
P00010eWave Electrode PatchWearlinq, Inc.DSH2026-04-02
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2026-03-09
17540279200027CardioSTATIcentia Inc.DSH2025-12-08
00884838127456Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2025-11-17
00884838127463Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2025-11-17
08800069700260AT-PatchATsens Co., Ltd.DSH2025-11-05
08800069700277AT-PatchATsens Co., Ltd.DSH2025-11-05
00884838127432Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2025-05-06
00884838127449Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2025-05-06
27540279250029CardioSTATIcentia Inc.DSH2024-12-18
27540279250074CardioSTATIcentia Inc.DSH2024-12-18
27540279250142CardioSTATIcentia Inc.DSH2024-12-18
00884838123717Care AssistPhilips Medical Systems HsgDSH2024-11-27
00884838123724Care AssistPhilips Medical Systems HsgDSH2024-11-27
00860007323409Vitals360Vocare, Inc.DSH2024-09-10
B146EP25R0ePatch Sensor 2.5, RebuiltBRAEMAR MANUFACTURING, LLCDSH2024-06-26
04250413405640ABPM pro basic deviceSOMNOmedics AGDSH2024-05-08
00815187020112Matrix WearableGLOBAL INSTRUMENTATION, LLCDSH2024-04-01
00815187020440Matrix WearableGLOBAL INSTRUMENTATION, LLCDSH2024-04-01
00815187020457Matrix WearableGLOBAL INSTRUMENTATION, LLCDSH2024-04-01
00815187020587Matrix WearableGLOBAL INSTRUMENTATION, LLCDSH2024-04-01
00815187020594Matrix WearableGLOBAL INSTRUMENTATION, LLCDSH2024-04-01
17540279105018EARTIcentia Inc.DSH2024-03-26
17540279200072CardioSTATIcentia Inc.DSH2024-03-26