Catalog Number

-

Brand Name

PremierPro

Version/Model Number

6211

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

6fa5738d-7bf0-4ced-82a1-a04d9f71d13a

Public Version Date

June 22, 2020

Public Version Number

4

DI Record Publish Date

June 15, 2016

Package DI Number

10818566013054

Quantity per Package

5

Contains DI Package

00818566013057

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case