Catalog Number

AMP0825

Brand Name

RespondER Emergency Rescue CPR Mask with Oxygen Port

Version/Model Number

AMP0825

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

CBP

Product Code Name

Valve, Non-Rebreathing

Public Device Record Key

420c5e2e-23f8-4f29-bbff-13c2af15c6d5

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 03, 2017

Package DI Number

00852696007029

Quantity per Package

150

Contains DI Package

00852696007012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case