Catalog Number

-

Brand Name

Vyaire

Version/Model Number

2009101-210

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

K040784,K040784,K040784

Product Code

DRX

Product Code Name

Electrode, Electrocardiograph

Public Device Record Key

9848fce7-b99a-4578-a17c-605dbadf0910

Public Version Date

December 17, 2018

Public Version Number

1

DI Record Publish Date

November 15, 2018

Package DI Number

28809083941363

Quantity per Package

10

Contains DI Package

18809083941366

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton Box