Duns Number:071595540
Device Description: STAT 2 PRIMARY ADMINISTRATIVE SET GRAVITY FLOW CONTROLLER
Catalog Number
S2-20 MD
Brand Name
STAT 2
Version/Model Number
S2-20 MD
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 29, 2022
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)
Yes
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
8211d4ff-ac26-4568-846f-e6358edbbd4d
Public Version Date
June 30, 2022
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
20653405027994
Quantity per Package
48
Contains DI Package
30653405027991
Package Discontinue Date
June 29, 2022
Package Status
Not in Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |