Duns Number:080935429
Device Description: Feeding Tube with IRIS Technology. For use with ENFit Connection System. Contains one (1) Feeding Tube with IRIS Technology. For use with ENFit Connection System. Contains one (1) Stylet per Feeding Tube. ENFit is a federally registered trademark in multiple jurisdictions throughout the wo
Catalog Number
461043E
Brand Name
Kangaroo
Version/Model Number
461043E
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
KNT
Product Code Name
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Public Device Record Key
a060ae7f-d05a-4d7a-ad8b-34e0dafcc03e
Public Version Date
June 17, 2019
Public Version Number
8
DI Record Publish Date
July 25, 2017
Package DI Number
10884521742192
Quantity per Package
5
Contains DI Package
20884521742199
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |