EKG Patch™ (Medium) MGMED

GUDID 10850018485002

Electrode, Electrocardiograph

NULINE SENSORS, LLC

Ambulatory recorder conductive patch

• Primary Device ID: 10850018485002
• NIH Device Record Key: 81b2f458-b454-4d13-8873-3cdf01fc343c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EKG Patch™ (Medium)
• Version Model Number: Medium
• Catalog Number: MGMED
• Company DUNS: 079231054
• Company Name: NULINE SENSORS, 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 407-473-0765
• Email: eve.gould@nulinesensors.com
• Phone: 407-473-0765
• Email: eve.gould@nulinesensors.com
• Phone: 407-473-0765
• Email: eve.gould@nulinesensors.com
• Phone: 407-473-0765
• Email: eve.gould@nulinesensors.com
• Phone: 407-473-0765
• Email: eve.gould@nulinesensors.com
• Phone: 407-473-0765
• Email: eve.gould@nulinesensors.com
• Phone: 407-473-0765
• Email: eve.gould@nulinesensors.com
• Phone: 407-473-0765
• Email: eve.gould@nulinesensors.com
• Phone: 407-473-0765
• Email: eve.gould@nulinesensors.com
• Phone: 407-473-0765
• Email: eve.gould@nulinesensors.com
• Phone: 407-473-0765
• Email: eve.gould@nulinesensors.com
• Phone: 407-473-0765
• Email: eve.gould@nulinesensors.com
• Phone: 407-473-0765
• Email: eve.gould@nulinesensors.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Light

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850018485005 [Primary]
GS1	10850018485002 [Package]; Contains: 00850018485005; Package: box [10 Units]; In Commercial Distribution

FDA Product Code

• DRX: Electrode, Electrocardiograph

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: 2020-07-09
• Device Publish Date: 2020-07-01

Devices Manufactured by NULINE SENSORS, LLC

• 10850018485002 - EKG Patch™ (Medium): 2020-07-09Electrode, Electrocardiograph
• 10850018485002 - EKG Patch™ (Medium): 2020-07-09 Electrode, Electrocardiograph
• 10850018485019 - EKG Patch™ (Large): 2020-07-09 Electrode, Electrocardiograph
• 00850018485029 - EKG Patch™ (Cable): 2020-07-09 Cable, Electrode