Catalog Number

-

Brand Name

Endurance Standard Alternating Pressure Bubble Pad w/Flaps

Version/Model Number

D8800EX

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

d7ee43d2-ad2b-4bd2-9520-9368c3f4fa61

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 07, 2017

Package DI Number

10754756388017

Quantity per Package

10

Contains DI Package

00754756388010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-