Duns Number:120818216
Device Description: 90" PRIMARY SOLUTION SET W/UNIV SPIKE, (2) INJ SITES, FLOW REGULATOR & ROTATING MLL
Catalog Number
KS-222-2
Brand Name
VYGON
Version/Model Number
KS-222-2
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
3b7f4da6-484f-43a4-a930-13fb1dc8aa89
Public Version Date
February 05, 2020
Public Version Number
1
DI Record Publish Date
January 28, 2020
Package DI Number
30849884003995
Quantity per Package
50
Contains DI Package
00849884003994
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 |