Duns Number:094651270
Device Description: A Polyurethane Enteral Feeding Tube, 5.0 Fr. - 58cm
Catalog Number
4165029P
Brand Name
NUTRI-CATH
Version/Model Number
Polyurethane Continuous
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K861090,K861090
Product Code
KNT
Product Code Name
Tubes, Gastrointestinal (And Accessories)
Public Device Record Key
2f6b451d-f38e-4554-a4b5-fc086a98ff4b
Public Version Date
December 19, 2019
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
H6714165029P1
Quantity per Package
10
Contains DI Package
H6714165029P0
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 | 35 |
2 | A medical device with a moderate to high risk that requires special controls. | 274 |