Catalog Number

-

Brand Name

M SERIES BIPHASIC

Version/Model Number

40010010100010013

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K990762

Product Code

DPS

Product Code Name

ELECTROCARDIOGRAPH

Public Device Record Key

eaa7456b-a8ab-4c03-a523-3cd8169542fe

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 08, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-