Catalog Number

HEAPR-01-001-01

Brand Name

HeartPrint

Version/Model Number

HEAPR-01-001-01

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

K183105

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

364b6c5f-fec6-4977-98ed-9c754412c9c2

Public Version Date

March 02, 2021

Public Version Number

1

DI Record Publish Date

February 22, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-