Catalog Number

-

Brand Name

Regard™

Version/Model Number

AN01041E

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

OKE

Product Code Name

Port Introducer Kit

Public Device Record Key

20c4689f-5121-475d-8ea1-3f6e1a836af2

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

December 10, 2019

Package DI Number

20194717105753

Quantity per Package

4

Contains DI Package

10194717105756

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-