Catalog Number

26099

Brand Name

BED MATTRESS-6X36X80-BASIC SINGLE LAYER FOAM-CAL117-NYLON

Version/Model Number

BM-63680-BF117-NY

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 10, 2021

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

IKY

Product Code Name

Mattress, Flotation Therapy, Non-Powered

Public Device Record Key

137fcb6f-10e2-49d3-b3e5-450de16046d7

Public Version Date

June 22, 2021

Public Version Number

2

DI Record Publish Date

April 17, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-