Catalog Number

-

Brand Name

Protevo

Version/Model Number

AF8-LE-35847RP

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)

-

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

a94376ef-b0ec-4265-9d7a-4714bc467118

Public Version Date

May 07, 2018

Public Version Number

1

DI Record Publish Date

April 04, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-