Duns Number:392994778
Device Description: Enteral feeding tube 10Fr Ø 2.0 x 3.3mm - L.50cm - PVC
Catalog Number
310.10
Brand Name
VYGON
Version/Model Number
310.10
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 16, 2019
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
7ca79c1f-2e1d-4ce9-a64d-a0c8621e6ae9
Public Version Date
October 23, 2020
Public Version Number
3
DI Record Publish Date
June 27, 2019
Package DI Number
33660812111943
Quantity per Package
50
Contains DI Package
03660812111942
Package Discontinue Date
December 16, 2019
Package Status
Not 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 |