Catalog Number

BM-H5-BR

Brand Name

Bathmate

Version/Model Number

Hydro 5 Brilliant Red

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

aa35b0c9-b7a6-4c84-87b1-e7a853e2184f

Public Version Date

April 09, 2020

Public Version Number

1

DI Record Publish Date

April 01, 2020

Package DI Number

05060140208327

Quantity per Package

10

Contains DI Package

05060140208297

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box