Catalog Number

E-45-S-0006

Brand Name

Hydrotherapy Whirlpool

Version/Model Number

E-45-S-0006

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

-

Product Code

ILJ

Product Code Name

Bath, Hydro-Massage

Public Device Record Key

fa5fb5d6-edfb-459f-a27b-4807b4056340

Public Version Date

August 14, 2018

Public Version Number

1

DI Record Publish Date

July 14, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-