Duns Number:080935429
Device Description: Polyurethane Feeding Tube,Radiopaque Line, Safe Enteral Connections
Catalog Number
-
Brand Name
Kangaroo
Version/Model Number
461042
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
0a64e6c1-3979-40dc-809b-842d82ac6103
Public Version Date
February 15, 2019
Public Version Number
5
DI Record Publish Date
October 20, 2016
Package DI Number
20884521067377
Quantity per Package
10
Contains DI Package
10884521067370
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 |