TelePatch Cardiac Monitor

GUDID 00862887000319

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.

MEDICOMP, INC.

Electrocardiograph, home-use

• Primary Device ID: 00862887000319
• NIH Device Record Key: 98851a7a-764b-4a7c-81e9-b134fbd0d51f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TelePatch Cardiac Monitor
• Version Model Number: PM800
• Company DUNS: 057729253
• Company Name: MEDICOMP, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 877-996-5553
• Email: patientsupport@reactdx.com
• Phone: 877-996-5553
• Email: patientsupport@reactdx.com
• Phone: 877-996-5553
• Email: patientsupport@reactdx.com
• Phone: 877-996-5553
• Email: patientsupport@reactdx.com
• Phone: 877-996-5553
• Email: patientsupport@reactdx.com
• Phone: 877-996-5553
• Email: patientsupport@reactdx.com
• Phone: 877-996-5553
• Email: patientsupport@reactdx.com
• Phone: 877-996-5553
• Email: patientsupport@reactdx.com
• Phone: 877-996-5553
• Email: patientsupport@reactdx.com
• Phone: 877-996-5553
• Email: patientsupport@reactdx.com
• Phone: 877-996-5553
• Email: patientsupport@reactdx.com
• Phone: 877-996-5553
• Email: patientsupport@reactdx.com
• Phone: 877-996-5553
• Email: patientsupport@reactdx.com
• Phone: 877-996-5553
• Email: patientsupport@reactdx.com
• Phone: 877-996-5553
• Email: patientsupport@reactdx.com
• Phone: 877-996-5553
• Email: patientsupport@reactdx.com
• Phone: 877-996-5553
• Email: patientsupport@reactdx.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862887000319 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161916

FDA Product Code

• DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-01
• Device Publish Date: 2024-07-24

On-Brand Devices [TelePatch Cardiac Monitor]

• 00862887000371: TelePatch CM PM700 is a small, auto triggered, or patient activated, device, prescribed by physi
• 00862887000388: TelePatch CM PM750 is a small, auto triggered, or patient activated, device, prescribed by physi
• 00862887000319: TelePatch CM PM800 is a small, auto triggered, or patient activated, device, prescribed by physi