EKG Patch Solution EPSK001CLPA020MG

GUDID 00198715993158

Portable, 12-lead ECG testing kit.

Mg Medical Products LLC

Electrocardiograph, professional, single-channel

• Primary Device ID: 00198715993158
• NIH Device Record Key: 354aecc1-9354-4675-9f80-4fb9fa0ef3ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EKG Patch Solution
• Version Model Number: 1
• Catalog Number: EPSK001CLPA020MG
• Company DUNS: 094834451
• Company Name: Mg Medical Products LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00198715993158 [Primary]

FDA Product Code

• OEZ: Cardiovascular Procedure Kit

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: 2024-12-27
• Device Publish Date: 2024-12-19

On-Brand Devices [EKG Patch Solution]

• 00198715993158: Portable, 12-lead ECG testing kit.
• 00860007764424: Portable, 12-lead ECG testing kit.