Catalog Number

-

Brand Name

Roscoe Medical

Version/Model Number

APP-CFX1

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

1b041f3b-592d-414f-8660-ef6efbb6832a

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

October 05, 2016

Package DI Number

40092237602049

Quantity per Package

4

Contains DI Package

00092237602041

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA