Duns Number:392994778
Device Description: Gastro-duodenal feeding tube, Levin type 16Fr Ø 3.5 x 5.0mm - L.125cm - PVC
Catalog Number
391.16
Brand Name
VYGON
Version/Model Number
391.16
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
KNT
Product Code Name
Tubes, gastrointestinal (and accessories)
Public Device Record Key
8d58302f-1221-4a04-9db7-111b69ded2b2
Public Version Date
October 04, 2019
Public Version Number
1
DI Record Publish Date
September 26, 2019
Package DI Number
53660812113545
Quantity per Package
4
Contains DI Package
33660812113541
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |