Catalog Number

-

Brand Name

LUMEX

Version/Model Number

AQ2000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

d6e0f03f-c694-4b20-831d-11f60c74f134

Public Version Date

July 25, 2019

Public Version Number

3

DI Record Publish Date

August 31, 2016

Package DI Number

M368AQ20002

Quantity per Package

4

Contains DI Package

M368AQ20001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-