Catalog Number

-

Brand Name

Regard™

Version/Model Number

CV0443

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 26, 2020

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

OEZ

Product Code Name

Cardiovascular Procedure Kit

Public Device Record Key

c37db823-4b91-4d48-a193-6858a5dc1adb

Public Version Date

August 27, 2020

Public Version Number

4

DI Record Publish Date

December 20, 2016

Package DI Number

20326053108291

Quantity per Package

2

Contains DI Package

10326053108294

Package Discontinue Date

October 25, 2018

Package Status

Not in Commercial Distribution

Package Type

-