Duns Number:360624720
Device Description: SEC SET 20DP 30IN W/HANGER LL
Catalog Number
72213N
Brand Name
Alaris
Version/Model Number
72213N
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
5f3a4263-f85f-4aad-a8ac-3594351f3092
Public Version Date
January 20, 2022
Public Version Number
5
DI Record Publish Date
September 22, 2016
Package DI Number
37613203010086
Quantity per Package
100
Contains DI Package
07613203010078
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 |