Catalog Number

-

Brand Name

Regard™

Version/Model Number

AN1026

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 26, 2020

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)

-

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

OKE

Product Code Name

Port Introducer Kit

Public Device Record Key

77da06a1-5274-4168-8432-ae2d00a2090b

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

March 26, 2018

Package DI Number

20326053114926

Quantity per Package

3

Contains DI Package

10326053114929

Package Discontinue Date

April 09, 2019

Package Status

Not in Commercial Distribution

Package Type

-