Catalog Number

-

Brand Name

Regard™

Version/Model Number

361099

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

0021b4b4-8e76-475d-8892-09757e795655

Public Version Date

March 24, 2020

Public Version Number

3

DI Record Publish Date

October 30, 2019

Package DI Number

10326053109352

Quantity per Package

100

Contains DI Package

00326053109355

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-