Catalog Number

-

Brand Name

M SERIES BIPHASIC

Version/Model Number

60021721110123010

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

f5c30c89-ab26-4dfd-93c6-c799eef4a122

Public Version Date

December 03, 2018

Public Version Number

1

DI Record Publish Date

October 31, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-