Catalog Number

-

Brand Name

Regard™

Version/Model Number

CV0500

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 19, 2019

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)

Yes

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

47cac5d6-287f-467f-8f57-588f676ec439

Public Version Date

September 20, 2019

Public Version Number

3

DI Record Publish Date

December 06, 2016

Package DI Number

20326053107324

Quantity per Package

1

Contains DI Package

10326053107327

Package Discontinue Date

September 19, 2019

Package Status

Not in Commercial Distribution

Package Type

-