Duns Number:429471691
Catalog Number
-
Brand Name
Enteral ENFit Transition Connector with cap for medication port
Version/Model Number
H93842907EN
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)
-
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
cd391499-33f9-4194-8a1a-57c5be767ae7
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 18, 2016
Package DI Number
08056093720099
Quantity per Package
30
Contains DI Package
08056093720082
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 |