Catalog Number

-

Brand Name

PremierPro

Version/Model Number

6212

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

-

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

BTM

Product Code Name

Ventilator, Emergency, Manual (Resuscitator)

Public Device Record Key

910c2f59-cc71-4c75-a7c4-5daae6dc7abe

Public Version Date

June 22, 2020

Public Version Number

4

DI Record Publish Date

June 15, 2016

Package DI Number

10818566013061

Quantity per Package

6

Contains DI Package

00818566013064

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case