Catalog Number

-

Brand Name

ELI 250c

Version/Model Number

ELI250c-CAA-ACCBX

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K101403

Product Code

DPS

Product Code Name

Electrocardiograph

Public Device Record Key

20d4c430-fcbe-4fef-a41b-b51955b24e86

Public Version Date

March 10, 2021

Public Version Number

6

DI Record Publish Date

December 15, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-