Duns Number:120818216
Device Description: 3FR X 20CM SINGLE LUMEN CT MIDLINE W/ STYLET
Catalog Number
VYML3S1003
Brand Name
VYGON
Version/Model Number
VYML3S1003
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
K181208,K181208
Product Code
PND
Product Code Name
Midline catheter
Public Device Record Key
e4a825bf-a4a6-4035-8ed3-1baa45c2e6b1
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
March 20, 2020
Package DI Number
30849884004862
Quantity per Package
5
Contains DI Package
00849884004861
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 |