Duns Number:120818216
Device Description: 105" IV ADMINISTRATION SET W/2 NEEDLELESS Y-SITES, CHECK VALVE & FILTER CAP
Catalog Number
VYCIS013
Brand Name
VYGON
Version/Model Number
VYCIS013
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K011336,K011336
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
b7383528-62ad-4566-9222-c3cfd547e76b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 28, 2017
Package DI Number
38498840010960
Quantity per Package
50
Contains DI Package
08498840010969
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 124 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 833 |