Catalog Number

-

Brand Name

WALGREENS

Version/Model Number

787917

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K190507,K190507

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

81fca8ce-8694-475c-ad2f-df69587d7442

Public Version Date

October 10, 2022

Public Version Number

1

DI Record Publish Date

September 30, 2022

Package DI Number

10311917132850

Quantity per Package

4

Contains DI Package

00311917132853

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case