Duns Number:543482946
Device Description: The cardiopulmonary resuscitation aid kit comprised of one CPR Mask with Oxygen Port, one The cardiopulmonary resuscitation aid kit comprised of one CPR Mask with Oxygen Port, one Infant CPR mask with 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 oxygen support (inhalation) or cardiopulmonary resuscitator (CPR) rescue techniques of a non-breathing patient. It also functions as a barrier to direct expired air from the patient away from the user.
Catalog Number
-
Brand Name
Compower
Version/Model Number
CP641000+CP641007+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)
Yes
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
08c733f7-12b1-4dc1-812c-fa638a73fa87
Public Version Date
August 21, 2019
Public Version Number
2
DI Record Publish Date
February 28, 2018
Package DI Number
16946430400540
Quantity per Package
50
Contains DI Package
06946430400543
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 |