Duns Number:120818216
Device Description: 10" WINGED SAFETY INFUSION SET WITH 19 GA. X 1" HUBER NEEDLE AND NEEDLELESS Y-SITE
Catalog Number
SHY-1910
Brand Name
VYGON
Version/Model Number
SHY-1910
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
K020544,K020544,K020544
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
2c5187fa-d300-4165-af39-2b166c56614e
Public Version Date
April 02, 2020
Public Version Number
1
DI Record Publish Date
March 25, 2020
Package DI Number
30849884004121
Quantity per Package
12
Contains DI Package
00849884004120
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 |