Duns Number:120818216
Device Description: 10" WINGED SAFETY INFUSION SET WITH 22 GA. X 1" HUBER NEEDLE
Catalog Number
SHS-2210
Brand Name
VYGON
Version/Model Number
SHS-2210
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
4817cc7c-e461-4209-be92-f28cb4443bfd
Public Version Date
April 02, 2020
Public Version Number
1
DI Record Publish Date
March 25, 2020
Package DI Number
50849884004118
Quantity per Package
21
Contains DI Package
30849884004114
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 |