Duns Number:052002029
Device Description: Polyurethane Enteral Feeding Tube, 16", 4FR, Approx. Priming Vol. 0.16 mL, TwistLok
Catalog Number
-
Brand Name
Enteral Feeding
Version/Model Number
ENPU1640
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K080328,K080328
Product Code
KNT
Product Code Name
Tubes, Gastrointestinal (And Accessories)
Public Device Record Key
fb2fe1af-277c-48b6-bf50-f9a034d55543
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 20, 2017
Package DI Number
20020451331083
Quantity per Package
10
Contains DI Package
00020451331089
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. | 244 |