Catalog Number

-

Brand Name

Regardo™

Version/Model Number

LD00044O

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 07, 2021

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)

Yes

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

MLS

Product Code Name

Labor And Delivery Kit

Public Device Record Key

75f46594-ff0b-4136-8502-0670de188dfb

Public Version Date

May 07, 2021

Public Version Number

3

DI Record Publish Date

January 22, 2020

Package DI Number

20194717106859

Quantity per Package

3

Contains DI Package

10194717106852

Package Discontinue Date

May 07, 2021

Package Status

Not in Commercial Distribution

Package Type

-