Catalog Number

-

Brand Name

Meridian Medical

Version/Model Number

1002F

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

80680b10-1000-4e9e-ad40-dad6623b3d32

Public Version Date

July 09, 2018

Public Version Number

3

DI Record Publish Date

October 18, 2016

Package DI Number

30815067042556

Quantity per Package

10

Contains DI Package

00081506704258

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA