Duns Number:825673239
Device Description: AMSure® Enteral Administration KitFOR USE WITH THE SENTINEL® ENTERAL FEEDING PUMPCONTENTS: AMSure® Enteral Administration KitFOR USE WITH THE SENTINEL® ENTERAL FEEDING PUMPCONTENTS:Enteral Feeding 500mL Bag Pump Set with ENFit Connector, ENFit Transition Connector
Catalog Number
ENF500K
Brand Name
AMSure® Enteral Administration Kit
Version/Model Number
2
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"
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
-
Product Code
KNT
Product Code Name
Tubes, Gastrointestinal (And Accessories)
Public Device Record Key
cf6b9843-3e56-4b67-9a44-abead73c4b11
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 03, 2017
Package DI Number
40704411006535
Quantity per Package
30
Contains DI Package
10704411006534
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 89 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 411 |
| U | Unclassified | 1 |