Duns Number:429471691
Catalog Number
-
Brand Name
Enteral Distal End ENFit Transition Connector
Version/Model Number
F00090
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 11, 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
a379a3d5-dd61-4464-8b03-6e686be93078
Public Version Date
October 12, 2021
Public Version Number
2
DI Record Publish Date
May 04, 2018
Package DI Number
08056093720464
Quantity per Package
80
Contains DI Package
08056093720334
Package Discontinue Date
October 11, 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 |