Catalog Number

2257

Brand Name

Immersus

Version/Model Number

Mattress 36"x84"x6"

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

February 19, 2040

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IKY

Product Code Name

Mattress, Flotation Therapy, Non-Powered

Public Device Record Key

4f80f157-0c0f-4632-ab47-9bb691c3b039

Public Version Date

February 28, 2020

Public Version Number

1

DI Record Publish Date

February 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-