Duns Number:121306984
Device Description: RespondER Emergency Rescue CPR Mask with Oxygen Port is a non-invasive face shield with an RespondER Emergency Rescue CPR Mask with Oxygen Port is a non-invasive face shield with an integral/removable non-rebreathing valve which serves as a physical barrier for rescuers providing immediate life support to health emergency victims requiring oxygen support or cardiopulmonary resuscitation (CPR) rescue techniques.
Catalog Number
AMP0826
Brand Name
RespondER Emergency Rescue CPR Mask with Oxygen Port in Clam Shell
Version/Model Number
AMP0826
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
06945e21-c282-4df9-a380-5094556c697b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 03, 2017
Package DI Number
00852696007067
Quantity per Package
100
Contains DI Package
00852696007050
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |