Duns Number:392994778
Device Description: Enteral feeding tube 08Fr Ø 1.5 x 2.5mm - L.75cm - PVC
Catalog Number
311.08
Brand Name
VYGON
Version/Model Number
311.08
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
44c41334-a0b5-46f6-9f44-0e8b7674eb4a
Public Version Date
October 04, 2019
Public Version Number
1
DI Record Publish Date
September 26, 2019
Package DI Number
53660812115433
Quantity per Package
18
Contains DI Package
33660812115439
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 |