Catalog Number

-

Brand Name

Regard™

Version/Model Number

243439

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K080189,K080189

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

c5f73817-be64-4a9e-844c-cbc910398f8a

Public Version Date

March 24, 2020

Public Version Number

2

DI Record Publish Date

October 30, 2019

Package DI Number

10326053104326

Quantity per Package

20

Contains DI Package

20326053104323

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-