QT ECG - The electrode is disposable with a sensing - QT MEDICAL, INC.

Duns Number:078875059

Device Description: The electrode is disposable with a sensing element and is designed for ECG. It is applied The electrode is disposable with a sensing element and is designed for ECG. It is applied to the surface of the body, single-use only, and disposable.

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More Product Details

Catalog Number

-

Brand Name

QT ECG

Version/Model Number

QTPOS124U

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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"

Yes

For Single-Use

Yes

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

DRX

Product Code Name

Electrode, Electrocardiograph

Device Record Status

Public Device Record Key

044ced13-2f1a-4a08-bd88-c148f10655e1

Public Version Date

July 12, 2021

Public Version Number

1

DI Record Publish Date

July 02, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"QT 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. 18