Catalog Number

BM-HM3-AB

Brand Name

Bathmate

Version/Model Number

Hydromax 3 Aqua Blue

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

Yes

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

-

Product Code

LKY

Product Code Name

Device, External Penile Rigidity

Public Device Record Key

3f8e1d63-9f23-43fa-9648-fce90c612b48

Public Version Date

March 09, 2021

Public Version Number

1

DI Record Publish Date

March 01, 2021

Package DI Number

05060140200833

Quantity per Package

10

Contains DI Package

05060140209195

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX