Catalog Number

-

Brand Name

Regard

Version/Model Number

CV01003H

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 19, 2021

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

OEZ

Product Code Name

Cardiovascular Procedure Kit

Public Device Record Key

e997fb69-956d-492b-a265-7fd7c5c1afb1

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

December 08, 2020

Package DI Number

20194717108730

Quantity per Package

1

Contains DI Package

10194717108733

Package Discontinue Date

February 19, 2021

Package Status

Not in Commercial Distribution

Package Type

-