FDA.reportPublic FDA data

TelePatch Cardiac Monitor

Primary DI
00862887000319
Brand
TelePatch Cardiac Monitor
Company
MEDICOMP, INC.
Model
PM800
Device description
TelePatch CM PM800 is a small, auto triggered, or patient activated, device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia.
Published
2024-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
MLOElectrocardiograph, Ambulatory, With Analysis Algorithm

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2
MLOElectrocardiograph, Ambulatory, With Analysis AlgorithmCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161916000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161916000TelePatch Cardiac MonitorMedicomp, Inc.2016-12-21DRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862887000319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862887000319008628870003198628870003190862887000319

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, home-useA device intended to be used by a layperson in the home to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It may be available with a variety of features [e.g., single-channel, multichannel, interpretive software, data telemetry]; electrodes may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-996-5553patientsupport@reactdx.com
877-996-5553customersupport@reactdx.com

Regulatory Flags#

DUNS number
057729253
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862887000302Epicardia 5000N/A2023-09-25
00862887000388TelePatch Cardiac MonitorPM7502023-09-25
00862887000340CardioPAL SAVIPM4102016-11-16
00862887000357Cardiac MonitorPM5002016-11-16
00862887000364Decipher Holter MonitorPM4612016-11-16
00862887000371TelePatch Cardiac MonitorPM7002016-11-16

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