Duns Number:392994778
Device Description: C-GON Syringe for safety connection Nutrisafe 2
Catalog Number
1015.102
Brand Name
VYGON
Version/Model Number
1015.102
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
19de65ec-7f58-43ed-b6bf-322fc00aece7
Public Version Date
October 29, 2021
Public Version Number
8
DI Record Publish Date
September 16, 2016
Package DI Number
53660812033829
Quantity per Package
12
Contains DI Package
33660812033825
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |