Catalog Number

-

Brand Name

Vyaire

Version/Model Number

2009110-003

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

K020003,K020003

Product Code

DRX

Product Code Name

Electrode, Electrocardiograph

Public Device Record Key

d5c12dd1-1a21-4c11-addf-de55071fde9a

Public Version Date

December 17, 2018

Public Version Number

1

DI Record Publish Date

November 15, 2018

Package DI Number

18809083941489

Quantity per Package

600

Contains DI Package

08809083941482

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box