Catalog Number

4132164

Brand Name

ESA 615

Version/Model Number

ESA615-10-NA220

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

-

Product Code

DRT

Product Code Name

Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Public Device Record Key

d22feff6-98bf-43a6-baff-30a0f3b60f56

Public Version Date

June 25, 2018

Public Version Number

1

DI Record Publish Date

May 24, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-