Catalog Number

-

Brand Name

4 chamber extension zipper

Version/Model Number

4ELGX01

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K150033,K202395,K203019,K203498,K150033,K202395,K203019,K203498,K150033,K202395,K203019,K203498,K150033,K202395,K203019,K203498,K150033,K202395,K203019,K203498

Product Code

IRP

Product Code Name

Massager, Powered Inflatable Tube

Public Device Record Key

2bb49a35-eea6-4c32-9b37-a8d015d63ff2

Public Version Date

December 27, 2021

Public Version Number

1

DI Record Publish Date

December 17, 2021

Package DI Number

18809802640631

Quantity per Package

5

Contains DI Package

08809802640634

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box