Catalog Number

5341

Brand Name

LIFESAVER

Version/Model Number

HD-5341

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)

Yes

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

5976916b-defb-4219-ae97-9410ad245571

Public Version Date

October 26, 2020

Public Version Number

4

DI Record Publish Date

September 28, 2016

Package DI Number

44710810093195

Quantity per Package

12

Contains DI Package

24710810093191

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton