Catalog Number

-

Brand Name

Regard™

Version/Model Number

GS00813

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)

-

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

OEV

Product Code Name

Cardiopulmonary Resuscitation Aid Kit

Public Device Record Key

f077f63c-35da-4cc9-846d-ceb8c0ef4c2b

Public Version Date

January 13, 2020

Public Version Number

1

DI Record Publish Date

January 03, 2020

Package DI Number

20194717102264

Quantity per Package

8

Contains DI Package

10194717102267

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-