Duns Number:052002029
Device Description: Enteral Extension Set, 60", Low Volume Minibore, Approx. Priming Vol. 1.30 mL, ENFit, Low Enteral Extension Set, 60", Low Volume Minibore, Approx. Priming Vol. 1.30 mL, ENFit, Low Dose
Catalog Number
-
Brand Name
Enteral Feeding
Version/Model Number
ENF06018LD
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
K895367,K895367
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
9b659771-8cfa-43b0-a5bf-c0db57ad39e5
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
20020451101341
Quantity per Package
100
Contains DI Package
00020451101347
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 |