Duns Number:120818216
Device Description: 115" ADMINISTRATION SET WITH 15 DROP/ML SPIKE DRIP CHAMBER AND THREE NEEDLELESS Y-SITES
Catalog Number
SS-933-1
Brand Name
VYGON
Version/Model Number
SS-933-1
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
d34058b4-b19b-4793-8869-5b9c858ba520
Public Version Date
December 24, 2019
Public Version Number
1
DI Record Publish Date
December 16, 2019
Package DI Number
30849884000413
Quantity per Package
50
Contains DI Package
00849884000412
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 |