Catalog Number

WGNBPA-950

Brand Name

Well at Walgreens

Version/Model Number

WGNBPA-950

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 01, 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

-

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

e95fa01b-57fe-464f-975e-7c52d01a0206

Public Version Date

August 16, 2021

Public Version Number

5

DI Record Publish Date

September 15, 2016

Package DI Number

10311917183401

Quantity per Package

4

Contains DI Package

00311917183404

Package Discontinue Date

November 01, 2019

Package Status

Not in Commercial Distribution

Package Type

Case