Duns Number:543482946
Device Description: Cardiopulmonary resuscitation kit contains CPR Mask with Oxygen Port and Infant CPR Mask w Cardiopulmonary resuscitation kit contains CPR Mask with Oxygen Port and Infant CPR Mask without Oxygen Port. CPR Mask with Oxygen Port is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques. Infant CPR Mask without Oxygen Port is designed for mouth to mask ventilation to health emergency patients requiring cardiopulmonary resuscitator (CPR) rescue techniques of a non-breathing patient. It also functions as a barrier that will direct expired air from the patient away from the user. It is intended for over the counter use for infants with body weight up to 10kg (22 lbs).
Catalog Number
-
Brand Name
compower
Version/Model Number
CP641000+CP641007
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
9249ae2c-048c-46e7-8922-7e79e1c9641f
Public Version Date
August 21, 2019
Public Version Number
2
DI Record Publish Date
February 28, 2018
Package DI Number
16946430400496
Quantity per Package
50
Contains DI Package
06946430400499
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 |