Catalog Number

-

Brand Name

Aeda

Version/Model Number

2M01M060022 Rev.B / MT-C4-231

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

268ca77f-cfe7-4bb5-b0e3-5c43d997a4a0

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

April 13, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-