Duns Number:147530323
Device Description: Feeding tube with ENFit Connectors non weighted
Catalog Number
40-1368
Brand Name
CORFLO Enteral Feeding Tube
Version/Model Number
40-1368
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"
-
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
-
Product Code
KNT
Product Code Name
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Public Device Record Key
ac75cba1-ac7d-4db6-906d-e694a424c372
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 24, 2016
Package DI Number
20815149020086
Quantity per Package
10
Contains DI Package
10815149020089
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 499 |