Duns Number:080935429
Device Description: Y-Site Extension with ENFit Connection, 6" (15.2 cm)
Catalog Number
8884705008E
Brand Name
Kangaroo
Version/Model Number
8884705008E
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
LZH
Product Code Name
Pump, Infusion, Enteral
Public Device Record Key
fc5e4cf7-ed57-4c24-9031-a793542df281
Public Version Date
December 27, 2019
Public Version Number
1
DI Record Publish Date
December 19, 2019
Package DI Number
40884521657619
Quantity per Package
30
Contains DI Package
30884521657612
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 |