Catalog Number

VLC-00-S/10

Brand Name

BlueSensor VLCECG Electrodes

Version/Model Number

VLC-00-S/10

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

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

f4893713-29d2-41d0-b5d2-d8ac67d16d02

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2016

Package DI Number

05707480004508

Quantity per Package

2

Contains DI Package

05707480022052

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-