Duns Number:360624720
Device Description: SmartSite 13mm Vial Access Device
Catalog Number
2203E
Brand Name
Alaris, SmartSite
Version/Model Number
2203E
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
1e6f7c31-1302-4f46-9a1a-c4d27038c9be
Public Version Date
April 27, 2020
Public Version Number
4
DI Record Publish Date
September 22, 2016
Package DI Number
37613203011809
Quantity per Package
2
Contains DI Package
27613203013851
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 43 |