Catalog Number

-

Brand Name

Meridian Medical

Version/Model Number

5010

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

FNM

Product Code Name

Mattress, Air Flotation, Alternating Pressure

Public Device Record Key

d9a343f9-8d5e-4d82-8521-ade81993a815

Public Version Date

August 20, 2019

Public Version Number

3

DI Record Publish Date

February 20, 2017

Package DI Number

30815067043386

Quantity per Package

2

Contains DI Package

00815067043385

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA