Well at Walgreens - Walgreens Earloop Face Mask - WALGREEN CO.

Duns Number:008965063

Device Description: Walgreens Earloop Face Mask

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More Product Details

Catalog Number

WRX153107

Brand Name

Well at Walgreens

Version/Model Number

WRX153107

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FXX

Product Code Name

Mask, Surgical

Device Record Status

Public Device Record Key

d9db7fbb-31d4-46a3-80c2-7ea57e0731b3

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

September 19, 2016

Additional Identifiers

Package DI Number

10311917141944

Quantity per Package

600

Contains DI Package

20311917141941

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"WALGREEN CO." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 75
2 A medical device with a moderate to high risk that requires special controls. 74
U Unclassified 2