Catalog Number

-

Brand Name

Meridian Medical

Version/Model Number

1105

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

0129078c-17be-4b49-9c1b-b9480dc0c34f

Public Version Date

July 09, 2018

Public Version Number

3

DI Record Publish Date

October 18, 2016

Package DI Number

30815067042563

Quantity per Package

5

Contains DI Package

00815067042562

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA