Catalog Number

-

Brand Name

4 chamber sleeve

Version/Model Number

4MDRF00

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K150033,K150033

Product Code

IRP

Product Code Name

Massager, Powered Inflatable Tube

Public Device Record Key

0bc7a933-8315-4992-a0aa-194847f50a99

Public Version Date

December 27, 2021

Public Version Number

1

DI Record Publish Date

December 17, 2021

Package DI Number

18809802640433

Quantity per Package

5

Contains DI Package

08809802640436

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box