Duns Number:080935429
Device Description: Safety Single Pass PEG Kit with ENFit Connection, 90 degree Bend, Pull
Catalog Number
762010E
Brand Name
Kangaroo
Version/Model Number
762010E
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
7feb6c0d-7492-4815-9cfa-6b40c5c8fd7a
Public Version Date
April 20, 2020
Public Version Number
7
DI Record Publish Date
May 23, 2018
Package DI Number
20884521703046
Quantity per Package
2
Contains DI Package
10884521703049
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 |