Catalog Number

-

Brand Name

Sapphire

Version/Model Number

27300015

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

81503652-6d1d-4162-99b1-7c818642c511

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

October 06, 2016

Package DI Number

30092237617954

Quantity per Package

4

Contains DI Package

00092237617953

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA