Catalog Number

937063

Brand Name

Well at Walgreens

Version/Model Number

100-021

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

K092245,K092245

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

6487db3f-d131-491b-b414-070d1c0541b8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 30, 2016

Package DI Number

03119171837562

Quantity per Package

24

Contains DI Package

00311917183756

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case