Catalog Number

WGNBPA-940

Brand Name

Well at Walgreens

Version/Model Number

WGNBPA-940

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

K161156,K161156

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

96ed3a41-614a-4f1a-8703-97772bdfd0cc

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

September 15, 2016

Package DI Number

10311917183395

Quantity per Package

4

Contains DI Package

00311917183398

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case