Duns Number:392994778
Device Description: Amber syringe for enteral drug administration
Catalog Number
1022.052
Brand Name
VYGON
Version/Model Number
1022.052
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
72de94a7-ca8f-4935-9b04-74dde8cba0d4
Public Version Date
October 29, 2021
Public Version Number
8
DI Record Publish Date
September 16, 2016
Package DI Number
53660812052998
Quantity per Package
24
Contains DI Package
33660812052994
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 |