Duns Number:080935429
Device Description: ENFit Transition Connector
Catalog Number
765000
Brand Name
Kangaroo
Version/Model Number
765000
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
PIO
Product Code Name
Enteral specific transition connectors
Public Device Record Key
ae189c21-4ce7-4af0-82d0-ec76a778b64d
Public Version Date
October 27, 2021
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
10884521515635
Quantity per Package
20
Contains DI Package
10884521212107
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pack or Inner Pack
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 |