Catalog Number

Not Applicable

Brand Name

Elite Mylar Blanket

Version/Model Number

ELITE-B100

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KME

Product Code Name

Bedding, Disposable, Medical

Public Device Record Key

dcc1532b-9b41-4307-9455-a36e16c88c59

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

April 20, 2021

Package DI Number

00816703023235

Quantity per Package

200

Contains DI Package

00816703023228

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case