Duns Number:066175613
Device Description: 8fr 80cm dual port feeding tube with ENFit connectors
Catalog Number
ENF-Y80P-80
Brand Name
Ameritus ENFit
Version/Model Number
ENF-Y80P-80
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
513aa804-07a0-452e-be6d-bae2db1a7a81
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 12, 2016
Package DI Number
30817522012449
Quantity per Package
200
Contains DI Package
10817522012445
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 |