Duns Number:392994778
Device Description: Nutrisafe 2 feeding tube with stylet 06Fr - L. 75cm - PUR
Catalog Number
1363.0621
Brand Name
VYGON
Version/Model Number
1363.0621
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
6d8ca11b-a700-49f7-9768-2cad7daf6267
Public Version Date
February 06, 2020
Public Version Number
1
DI Record Publish Date
January 29, 2020
Package DI Number
33660812114838
Quantity per Package
25
Contains DI Package
03660812114837
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 |