Duns Number:365581688
Device Description: Three Port Flexible Manifold w/Split Septum Needle-Free Valves and Integrated Back Check V Three Port Flexible Manifold w/Split Septum Needle-Free Valves and Integrated Back Check Valves
Catalog Number
-
Brand Name
FlowArt®
Version/Model Number
AYWB4010CV
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"
Yes
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
K190806,K190806
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
29d7207a-d0ee-47b7-9a3a-b0afbd111f57
Public Version Date
May 09, 2022
Public Version Number
1
DI Record Publish Date
April 29, 2022
Package DI Number
28699443585067
Quantity per Package
50
Contains DI Package
08699443585063
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |