Duns Number:884153748
Device Description: Enteral Feeding Pump Spike Set, ENFit, adapter, NS
Catalog Number
EN-1004SP
Brand Name
Alcor SENTINELplus
Version/Model Number
EN-1004SP
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 23, 2017
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"
Yes
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
K902641
Product Code
KNT
Product Code Name
Tubes, Gastrointestinal (And Accessories)
Public Device Record Key
b8418803-f2b4-4244-ae8c-fc562fd1388e
Public Version Date
October 23, 2019
Public Version Number
4
DI Record Publish Date
March 23, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |