Catalog Number

-

Brand Name

Regard™

Version/Model Number

HT00235L

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

-

Product Code

OES

Product Code Name

Cardiac Catheterization Kit

Public Device Record Key

7c891ad2-4ff9-4695-974d-a2764a5c5300

Public Version Date

November 01, 2019

Public Version Number

1

DI Record Publish Date

October 24, 2019

Package DI Number

20194717104022

Quantity per Package

2

Contains DI Package

10194717104025

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-