Heartrak Smart AF - Transmitters and Receivers, Electrocardiograph, - UNIVERSAL MEDICAL, INC.

Duns Number:803593073

Device Description: Transmitters and Receivers, Electrocardiograph, Telephone

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More Product Details

Catalog Number

-

Brand Name

Heartrak Smart AF

Version/Model Number

Heartrak Smart AF

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

DXH

Product Code Name

Transmitters And Receivers, Electrocardiograph, Telephone

Device Record Status

Public Device Record Key

4d088949-cb15-4bdb-9230-f6e8614dd7f7

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 21, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"UNIVERSAL MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 15