Catalog Number

HD-5461

Brand Name

LIFESAVER

Version/Model Number

5461

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)

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

6d420f97-b8c5-4a4d-890a-cfb4ba6470ed

Public Version Date

October 26, 2020

Public Version Number

4

DI Record Publish Date

September 19, 2015

Package DI Number

44710810093003

Quantity per Package

6

Contains DI Package

04710810093005

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton