TelePatch Cardiac Monitor

Basic Information

• Brand Name: TelePatch Cardiac Monitor
• Primary DI: 00862887000319
• Version / Model: PM800
• Company Name: MEDICOMP, INC.
• Labeler DUNS: 057729253
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-24
• Public Version: 1
• Public Version Date: 2024-08-01
• Public Version Status: New
• Public Device Record Key: 98851a7a-764b-4a7c-81e9-b134fbd0d51f

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	870.2910	2
MLO	Electrocardiograph, Ambulatory, With Analysis Algorithm	Cardiovascular	870.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62641	Electrocardiograph, home-use	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00862887000319	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K161916	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 140 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity