Duns Number:120818216
Device Description: 3ML SYRINGE FOR SAFETY CONNECTION NUTRISAFE 2
Catalog Number
1015.032M
Brand Name
VYGON
Version/Model Number
1015.032M
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K060944,K060944,K060944
Product Code
KNT
Product Code Name
Tubes, gastrointestinal (and accessories)
Public Device Record Key
de5d2399-f643-4c50-926f-bc24479cd40d
Public Version Date
October 29, 2021
Public Version Number
2
DI Record Publish Date
March 13, 2020
Package DI Number
30849884000888
Quantity per Package
100
Contains DI Package
00849884000887
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 | 124 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 833 |