Catalog Number

-

Brand Name

Regard

Version/Model Number

CV00966B

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)

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

10daf368-08df-4e20-b993-a8f515092f27

Public Version Date

December 18, 2020

Public Version Number

1

DI Record Publish Date

December 10, 2020

Package DI Number

20194717108945

Quantity per Package

2

Contains DI Package

10194717108948

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-