Duns Number:053006828
Device Description: Mechanical CPR system, including Battery Control Unit, Compressor, Torso Restraints (10 pk Mechanical CPR system, including Battery Control Unit, Compressor, Torso Restraints (10 pk), Torso Restraints XL (5 pk), Battery Charger
Catalog Number
A03-01-000
Brand Name
ROSC-U System
Version/Model Number
A03-01-000
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
-
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
DRM
Product Code Name
Compressor, Cardiac, External
Public Device Record Key
b1212136-6466-469e-99f1-37487c856806
Public Version Date
December 23, 2019
Public Version Number
1
DI Record Publish Date
December 13, 2019
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |