Catalog Number

6614PP

Brand Name

PremierPro

Version/Model Number

6614PP

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"

Yes

For Single-Use

Yes

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

7b915000-4753-414d-86e0-afc335610ee0

Public Version Date

February 21, 2022

Public Version Number

2

DI Record Publish Date

September 08, 2020

Package DI Number

10818566017922

Quantity per Package

6

Contains DI Package

00818566017925

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case