Heartrak ECAT

GUDID B147HTECAT010

Transmitters and Receivers, Electrocardiograph, Telephone

UNIVERSAL MEDICAL, INC.

Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system

• Primary Device ID: B147HTECAT010
• NIH Device Record Key: b17fe249-2c47-411c-8ecd-3fd05af959be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Heartrak ECAT
• Version Model Number: Heartrak ECAT
• Company DUNS: 803593073
• Company Name: UNIVERSAL MEDICAL, 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B147HTECAT010 [Primary]

FDA Product Code

• DXH: Transmitters And Receivers, Electrocardiograph, Telephone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-01-21

Devices Manufactured by UNIVERSAL MEDICAL, INC.

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• B147CA0 - Cardiostation® Advantage Software: 2018-03-29 Cardiostation Software sold with TTM module.
• B147CBECAT0 - Heartrak ECAT Patient Cable: 2018-03-29 Electrode cable
• B147CSS0 - Cardiostation Premier Stand Alone Software: 2018-03-29 Cardiostation Software sold with wireless devices.
• B147CSTTM010 - Cardiostation Transtelephonic Module: 2018-03-29 Transmitters and Receivers, Electrocardiograph, Telephone
• B147EC0 - eCardiostation Software: 2018-03-29 Software with CardioStation
• B147FSAIR0 - Fusion Air: 2018-03-29 Transmitters and Receivers, Electrocardiograph, Telephone
• B147HT20 - Heartrak 2: 2018-03-29 Telephone electrocardiograph transmitter and receiver