Catalog Number

32028778 50601-US

Brand Name

Claravue

Version/Model Number

CLARAVUE PM M5 RT US

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,K101685,K101685

Product Code

DRX

Product Code Name

Electrode, Electrocardiograph

Public Device Record Key

a7df2607-c58c-4382-ab8d-850c174d1e69

Public Version Date

April 20, 2022

Public Version Number

4

DI Record Publish Date

July 13, 2021

Package DI Number

13700506300119

Quantity per Package

30

Contains DI Package

03700506300112

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box