Duns Number:429471691
Catalog Number
-
Brand Name
Enteral ENFit Transition Connector with cap for medication port
Version/Model Number
F00073
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 03, 2021
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
2e144f82-39c6-43d0-9cdf-a15974fd2b39
Public Version Date
June 07, 2021
Public Version Number
3
DI Record Publish Date
December 28, 2017
Package DI Number
08056093720136
Quantity per Package
24
Contains DI Package
08056093720129
Package Discontinue Date
June 03, 2021
Package Status
Not 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 |