Catalog Number

RVP4735

Brand Name

RhythmView

Version/Model Number

RVP4735

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"

-

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

5b0cd1b2-4ca4-41b9-81f1-507d846fe1ff

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 02, 2016

Package DI Number

30810591020209

Quantity per Package

10

Contains DI Package

00810591020208

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box