Duns Number:392994778
Device Description: Nutrisafe2 - Feeding tube, closed tip, with stylet - 14Fr - L.75cm - PUR
Catalog Number
1363.1421
Brand Name
VYGON
Version/Model Number
1363.1421
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
FPD
Product Code Name
TUBE, FEEDING
Public Device Record Key
668e143c-d9b5-4a70-bd1f-6209ac23e70d
Public Version Date
August 16, 2021
Public Version Number
1
DI Record Publish Date
August 06, 2021
Package DI Number
33660812136687
Quantity per Package
25
Contains DI Package
03660812136686
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 |