Catalog Number

-

Brand Name

APEX

Version/Model Number

Serene Elite with 8" Mattress

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FNM

Product Code Name

Mattress, Air Flotation, Alternating Pressure

Public Device Record Key

83b2cdf8-a6ec-4c26-b998-c478e280ebda

Public Version Date

August 06, 2018

Public Version Number

1

DI Record Publish Date

July 04, 2018

Package DI Number

14713025004382

Quantity per Package

2

Contains DI Package

04713025004385

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-