Catalog Number

-

Brand Name

Walgreens

Version/Model Number

243398

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

K201645,K201645

Product Code

IRP

Product Code Name

Massager, Powered Inflatable Tube

Public Device Record Key

7d28e953-aec4-4ff6-8e67-b242f973ea6c

Public Version Date

March 11, 2022

Public Version Number

1

DI Record Publish Date

March 03, 2022

Package DI Number

10311917137381

Quantity per Package

12

Contains DI Package

00311917137384

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case