Duns Number:080935429
Device Description: Irrigation Kit with 500 mL Container,60 mL Piston Syringe
Catalog Number
84066
Brand Name
Kangaroo
Version/Model Number
84066
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
-
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
FPD
Product Code Name
TUBE, FEEDING
Public Device Record Key
79dce412-bacd-40e0-9320-bcd5e0683523
Public Version Date
February 15, 2019
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
20884521002101
Quantity per Package
30
Contains DI Package
10884521002104
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 |