Duns Number:429471691
Catalog Number
-
Brand Name
Enteral Funnel ENFIt Transition Connector with cap
Version/Model Number
F00106
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"
Yes
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
dbfa9187-6971-433e-bdde-6ff384f9d8ca
Public Version Date
August 03, 2018
Public Version Number
1
DI Record Publish Date
July 03, 2018
Package DI Number
08056093720310
Quantity per Package
24
Contains DI Package
08056093720303
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 29 |