Midmark IQholter EX Digital Holter - The Midmark IQholter EX system combines a compact - MIDMARK CORPORATION

Duns Number:005036025

Device Description: The Midmark IQholter EX system combines a compact digital recorder with three powerful sof The Midmark IQholter EX system combines a compact digital recorder with three powerful software applications. Includes the standard features of IQholter with expanded functionality for A-Fib, QT/QTc and HRV analysis, template editing, Smart Page Scan and more. Kit includes: Midmark IQholter Recorder (includes lead wire set, secure digital card), Reusable IQholter Recorder pouch and Belt, Secure Digital Card Reader, Software Security Key, USB Version, and Holter Prep Kits.

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More Product Details

Catalog Number

4-000-0113

Brand Name

Midmark IQholter EX Digital Holter

Version/Model Number

4-000-0113

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

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

MLO

Product Code Name

Electrocardiograph, Ambulatory, With Analysis Algorithm

Device Record Status

Public Device Record Key

a0de59bb-8d48-497b-a37e-9e04beef3536

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MIDMARK CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 838
2 A medical device with a moderate to high risk that requires special controls. 544