Duns Number:078875059
Device Description: The QT ECG Disposable Electrode Strip is a self-adhesive, single use, one-piece integrated The QT ECG Disposable Electrode Strip is a self-adhesive, single use, one-piece integrated ECG electrode meant to use with QT ECG recorder. The design of the prepositioned Electrode Strip gives the user an easy way of applying the collection of electrodes in their correct locations, thereby reducing electrode placement errors.
Catalog Number
-
Brand Name
QT ECG
Version/Model Number
QTEOS121A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
DRX
Product Code Name
Electrode, Electrocardiograph
Public Device Record Key
694614d1-fabc-41d5-babf-d8a7d26c1d7a
Public Version Date
December 31, 2019
Public Version Number
5
DI Record Publish Date
November 30, 2018
Package DI Number
14719872980114
Quantity per Package
120
Contains DI Package
04719872980117
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |