Duns Number:360624720
Device Description: SE W/150 MC, 0.2 MF 3VS DEHP FREE
Catalog Number
11141556
Brand Name
Alaris, VersaSafe, Signature Edition
Version/Model Number
11141556
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
9b29e786-22d0-4d03-865f-485f8def3041
Public Version Date
April 27, 2020
Public Version Number
4
DI Record Publish Date
February 07, 2017
Package DI Number
70885403422234
Quantity per Package
49
Contains DI Package
50885403422230
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pallet
| 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 |