eCardiostation Software

GUDID B147EC0

Software with CardioStation

UNIVERSAL MEDICAL, INC.

Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system

• Primary Device ID: B147EC0
• NIH Device Record Key: 9e7bc6c8-8853-47ce-9adc-4928b991feaa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eCardiostation Software
• Version Model Number: eCardiostation Software
• 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: true
• Serial Number: false
• 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	B147EC0 [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: 2017-02-12

Devices Manufactured by UNIVERSAL MEDICAL, INC.

• B14731161 - Pacetrak Plus rev 3: 2018-03-29 Transmitters and Receivers, Electrocardiograph, Telephone
• 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: 2018-03-29Software with CardioStation
• 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