TelePatch Cardiac Monitor

GUDID 00862887000371

TelePatch CM PM700 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.

Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder

• Primary Device ID: 00862887000371
• NIH Device Record Key: 374feb27-cf32-478b-af1e-b90e0c4f0b8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TelePatch Cardiac Monitor
• Version Model Number: PM700
• 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

Operating and Storage Conditions

• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862887000371 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091696

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-11-16

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