Duns Number:038101861
Device Description: Y-Port-to-Female Enfit® Adapter (Pouched)
Catalog Number
ETRN203, TRN203
Brand Name
AMT Enfit® Transition Adapter
Version/Model Number
ETRN203
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
K150034,K150034
Product Code
PIO
Product Code Name
Enteral Specific Transition Connectors
Public Device Record Key
63a74b26-229f-452a-a9fe-b7d13b3a76fd
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 31, 2016
Package DI Number
00842071109097
Quantity per Package
10
Contains DI Package
00842071108038
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box (TRN203)
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 26 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1325 |