Duns Number:392994778
Device Description: Umbilical catheter 4Fr – L.20cm – PUR (double lumen - 11ml/min / 12ml/min)
Catalog Number
1274.14
Brand Name
VYGON
Version/Model Number
1274.14
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FOS
Product Code Name
CATHETER, UMBILICAL ARTERY
Public Device Record Key
3461d87e-964f-4198-8f1c-b6cb5eb5046c
Public Version Date
August 16, 2021
Public Version Number
1
DI Record Publish Date
August 06, 2021
Package DI Number
33660812130890
Quantity per Package
10
Contains DI Package
03660812130899
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 195 |