Duns Number:392994778
Device Description: Nutrisafe 2 extension tubes Ø 1.5 x 2.5mm - L.30cm
Catalog Number
368.032
Brand Name
VYGON
Version/Model Number
368.032
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
b9c0ee33-282e-435f-85a6-a2eed1b14a4e
Public Version Date
October 16, 2019
Public Version Number
2
DI Record Publish Date
June 27, 2019
Package DI Number
33660812107892
Quantity per Package
50
Contains DI Package
03660812107891
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 |