Duns Number:543482946
Device Description: The cardiopulmonary resuscitation aid kit comprises of one CPR mask without Oxygen Port, t The cardiopulmonary resuscitation aid kit comprises of one CPR mask without Oxygen Port, two pieces alcohol pads and one pair PVC glove. This kit is designed for mouth to mask ventilation to health emergency patients requiring cardiopulmonary resuscitator (CPR) rescue techniques of a non-breathing patient. It functions as a barrier to direct expired air from the patient away from the user. It can be used with supplemental oxygen when needed.
Catalog Number
-
Brand Name
Ever One
Version/Model Number
CP641002+2A+PG
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
-
Product Code Name
-
Public Device Record Key
d1b195cd-6f13-4f81-a6b4-5ba0cea6870a
Public Version Date
November 23, 2018
Public Version Number
1
DI Record Publish Date
October 23, 2018
Package DI Number
16946430401202
Quantity per Package
50
Contains DI Package
06946430401205
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 34 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |