Duns Number:066175613
Device Description: 6fr 90cm dual port feeding tube with ENFit connector
Catalog Number
ENF-Y60P-90U
Brand Name
Ameritus ENFit
Version/Model Number
ENF-Y60P-90U
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
K100526,K100526,K100526
Product Code
FPD
Product Code Name
Tube, Feeding
Public Device Record Key
061aaf49-694c-47f7-9dc7-acfa12499c18
Public Version Date
July 18, 2019
Public Version Number
2
DI Record Publish Date
June 20, 2018
Package DI Number
30817522013101
Quantity per Package
200
Contains DI Package
10817522013107
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| 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. | 44 |