Duns Number:482489007
Device Description: Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1x Remote Co Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1x Remote Control GTIN : 376300393004711 x EDA Module Kit GTIN : 376300393004261 x EmpowerSync® Power Supply GTIN : 376300393008391 x Injector GTIN : 37630039300822
Catalog Number
017383
Brand Name
EmpowerCTA®+ Injector System with EDA
Version/Model Number
017383
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
DSB
Product Code Name
Plethysmograph, Impedance
Public Device Record Key
d97ebe67-cf7e-4e0a-bb9f-e7e440aabaeb
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 26, 2017
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. | 84 |