Duns Number:080216804
Device Description: Sovea™ Gastrostomy Feeding Tube with Y Ports, 14FR 10ml ENFit Connector, Sterile
Catalog Number
ITG-41410
Brand Name
Sovea™
Version/Model Number
ITG-41410
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"
Yes
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
K092418,K092418,K092418
Product Code
KNT
Product Code Name
Tubes, Gastrointestinal (And Accessories)
Public Device Record Key
4d23bf43-d08f-423a-b788-266c714fe507
Public Version Date
May 11, 2020
Public Version Number
3
DI Record Publish Date
February 10, 2020
Package DI Number
50850009501283
Quantity per Package
6
Contains DI Package
30850009501289
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 54 |