Catalog Number

-

Brand Name

CardioInsight™

Version/Model Number

CITVST0002M

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

Yes

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

K162440

Product Code

DQK

Product Code Name

COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Public Device Record Key

62b6de59-7f57-4e8a-974e-3de6befa93a3

Public Version Date

September 18, 2018

Public Version Number

1

DI Record Publish Date

August 18, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-