Catalog Number

-

Brand Name

Aeda

Version/Model Number

1M01M060059 Rev.E / MT-S4-025

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

5d1e2fe2-843c-463a-908e-d1eca9c48186

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

September 10, 2017

Package DI Number

04897079030153

Quantity per Package

4

Contains DI Package

04897079030139

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Big Carton