Duns Number:482489007
Catalog Number
-
Brand Name
EmpowerSync® Power Supply
Version/Model Number
017353
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
IZQ
Product Code Name
Injector, Contrast Medium, Automatic
Public Device Record Key
53be0fd6-3cdd-4a5f-8f9c-3baabca0d0f7
Public Version Date
May 12, 2020
Public Version Number
1
DI Record Publish Date
May 04, 2020
Package DI Number
37630039300945
Quantity per Package
1
Contains DI Package
17630039300958
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 84 |