Catalog Number

-

Brand Name

Regard™

Version/Model Number

303404

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

47328a2b-c4ca-47fe-8898-e632ffd4d689

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

October 30, 2019

Package DI Number

10326053105262

Quantity per Package

100

Contains DI Package

20326053105269

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-