Duns Number:825673239
Device Description: AMSure® Enteral Administration KitCONTENTS:Enteral Feeding 500mL Bag Pump Set with ENFit C AMSure® Enteral Administration KitCONTENTS:Enteral Feeding 500mL Bag Pump Set with ENFit Connector, ENFit Transition Connector
Catalog Number
ENF500K
Brand Name
AMSure® Enteral Administration Kit
Version/Model Number
1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 03, 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)
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
69ef3ee1-cb5a-4392-84da-1f18dc542808
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 2016
Package DI Number
40704411004951
Quantity per Package
30
Contains DI Package
10704411004950
Package Discontinue Date
July 03, 2017
Package Status
Not 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 |