EKG Patch™ (Large) - Electrode, Electrocardiograph - NULINE SENSORS, LLC

Duns Number:079231054

Device Description: Electrode, Electrocardiograph

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More Product Details

Catalog Number

MGLRG

Brand Name

EKG Patch™ (Large)

Version/Model Number

Large

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"

Yes

For Single-Use

Yes

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

DRX

Product Code Name

Electrode, Electrocardiograph

Device Record Status

Public Device Record Key

06fce679-7028-4ed7-85fe-8accb9422ba8

Public Version Date

July 09, 2020

Public Version Number

1

DI Record Publish Date

July 01, 2020

Additional Identifiers

Package DI Number

10850018485019

Quantity per Package

10

Contains DI Package

00850018485012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"NULINE SENSORS, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3