Catalog Number

-

Brand Name

Well at Walgreens

Version/Model Number

899838

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

K153214,K153214

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

e7e07eb0-b232-403f-8576-073d68e4d0f1

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

May 01, 2019

Package DI Number

10311917207008

Quantity per Package

4

Contains DI Package

00311917207001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-