Catalog Number

32028776 50401-US

Brand Name

CLARAVUE

Version/Model Number

CLARAVUE PM NEONAT/PEDIATRIC 3 RT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K101685

Product Code

DRX

Product Code Name

Electrode, Electrocardiograph

Public Device Record Key

9d06fe8c-4fa2-4061-9458-051eb4a12b9d

Public Version Date

April 27, 2022

Public Version Number

1

DI Record Publish Date

April 19, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-