Duns Number:730624095
Device Description: The CPRmeter 2 CPR feedback device is a portable, battery-powered device intended to provi The CPRmeter 2 CPR feedback device is a portable, battery-powered device intended to provide real-time feedback on manual chest compression (i.e depth of compression) performed during cardiopulmonary resuscitation (CPR) on a patient in cardiac arrest, or during training on a resuscitation training model. It typically consists of a chest plate with a digital display, which is placed on the sternum and pushed down during chest compression and will display compression depth and rate, measured by one of various electronic technologies (e.g., electromagnetic signaling to a baseplate, accelerometer). It is intended to be used by those trained in CPR.
Catalog Number
801-00249
Brand Name
CPRmeter 2 (Multi-bundle)
Version/Model Number
801
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
-
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
LIX
Product Code Name
Aid, Cardiopulmonary Resuscitation
Public Device Record Key
c4b8564d-101c-4087-8aa6-ac6c0bd71fad
Public Version Date
January 03, 2019
Public Version Number
5
DI Record Publish Date
November 28, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 80 |