Duns Number:052002029
Device Description: Polyurethane Enteral Feeding Tube, 42", 10FR, Approx. Priming Vol. 3.20 mL, ENFit, Low Dos Polyurethane Enteral Feeding Tube, 42", 10FR, Approx. Priming Vol. 3.20 mL, ENFit, Low Dose
Catalog Number
-
Brand Name
Enteral Feeding
Version/Model Number
ENFPU42100LD
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
cf37de7d-1598-44c9-adba-c341b059b6ef
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
20020451101570
Quantity per Package
10
Contains DI Package
00020451101576
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 |