Duns Number:120818216
Device Description: 4FR X 20CM SINGLE LUMEN MIDLINE MAX BARRIER KIT
Catalog Number
VYML4S3001A
Brand Name
VYGON
Version/Model Number
VYML4S3001A
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
559dfb1e-4ab2-49f9-82c1-e19e7c25d1d0
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
April 14, 2020
Package DI Number
30849884004930
Quantity per Package
4
Contains DI Package
00849884004939
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 |