Catalog Number

-

Brand Name

Meridian

Version/Model Number

Q5

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

cce44af3-7c96-47fd-aa99-b50a1c05acc1

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 28, 2016

Package DI Number

30815067042723

Quantity per Package

2

Contains DI Package

00815067042722

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-