Duns Number:038101861
Device Description: 24" Mini ONE® RIGHT ANGLE Non-PVC Feeding Set with Dual ENFit ® Y-PORT (Pouched)
Catalog Number
E8-2455-ISOSAF-NP; 8-2455-ISOSAF-NP
Brand Name
AMT Mini ONE® Extension Set
Version/Model Number
E8-2455-ISOSAF-NP
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
K142989,K971757,K142989,K971757
Product Code
KNT
Product Code Name
Tubes, Gastrointestinal (And Accessories)
Public Device Record Key
57fc8718-bd9f-4d1b-be9c-a35bd1e3cb1f
Public Version Date
November 29, 2021
Public Version Number
1
DI Record Publish Date
November 19, 2021
Package DI Number
00842071129262
Quantity per Package
10
Contains DI Package
00842071129101
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |