Catalog Number

-

Brand Name

Regard

Version/Model Number

405218REG

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LRS

Product Code Name

I.V. start kit

Public Device Record Key

804b46e4-ee5d-42fd-912b-cc217e85644a

Public Version Date

May 02, 2022

Public Version Number

1

DI Record Publish Date

April 22, 2022

Package DI Number

20809160369484

Quantity per Package

100

Contains DI Package

10809160369487

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-