Catalog Number

-

Brand Name

Roscoe Medical

Version/Model Number

APP-DLXP

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

536caecb-fcdc-4517-961d-24609fc2ca13

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 05, 2016

Package DI Number

80092237602054

Quantity per Package

10

Contains DI Package

00092237602058

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

ca