Catalog Number

-

Brand Name

Regard™

Version/Model Number

CV0851

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 26, 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

0c307730-0994-4160-96b5-2c0fddcf6cd4

Public Version Date

September 27, 2019

Public Version Number

3

DI Record Publish Date

January 12, 2017

Package DI Number

20326053112922

Quantity per Package

1

Contains DI Package

10326053112925

Package Discontinue Date

September 26, 2019

Package Status

Not in Commercial Distribution

Package Type

-