Heartrak Smart AF

GUDID B147HTSMAF50

Transmitters and Receivers, Electrocardiograph, Telephone

UNIVERSAL MEDICAL, INC.

Electrocardiography telemetric monitoring system

• Primary Device ID: B147HTSMAF50
• NIH Device Record Key: 4d088949-cb15-4bdb-9230-f6e8614dd7f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Heartrak Smart AF
• Version Model Number: Heartrak Smart AF
• 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	B147HTSMAF50 [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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