Duns Number:360624720
Device Description: AS LVP 20D 3SS CV
Catalog Number
2426-0007
Brand Name
Alaris, SmartSite
Version/Model Number
2426-0007
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
edf342cf-013f-45ce-a323-c42a7e362f4b
Public Version Date
January 20, 2022
Public Version Number
5
DI Record Publish Date
September 22, 2016
Package DI Number
50885403227996
Quantity per Package
20
Contains DI Package
10885403227998
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelfpack
| 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 |