Catalog Number

-

Brand Name

CORE12

Version/Model Number

C18006

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

K103706

Product Code

DSI

Product Code Name

Detector And Alarm, Arrhythmia

Public Device Record Key

47b9d0b7-7f82-4fda-b2a8-c1ea0c5ae5e1

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

March 27, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-