Catalog Number

-

Brand Name

Regard

Version/Model Number

R39268

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 31, 2019

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K032821,K032821

Product Code

NPP

Product Code Name

Reprocessed Blood Pressure Cuff

Public Device Record Key

8a8d7f6b-8769-47ce-8c88-a8f968a8997f

Public Version Date

March 19, 2021

Public Version Number

4

DI Record Publish Date

September 29, 2016

Package DI Number

30817357021876

Quantity per Package

20

Contains DI Package

10817357021872

Package Discontinue Date

March 19, 2021

Package Status

Not in Commercial Distribution

Package Type

Box