Duns Number:825673239
Device Description: The Enteral Feeding Syringe with ENFit Tip connection is intended to connect to Enteral de The Enteral Feeding Syringe with ENFit Tip connection is intended to connect to Enteral devices with ENFit connectors.CONTENTS:- 60cc Flat Top Piston Syringe(China)- ENFit transition connector(China) - Tip Protector(China)
Catalog Number
ENS115T
Brand Name
AMSure ® Enteral Feeding Flat Top Piston Syringe with ENFit ™ Tip
Version/Model Number
1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 04, 2022
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
-
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
45a32c94-7ab8-4f0a-a698-31074f3c039b
Public Version Date
October 12, 2022
Public Version Number
1
DI Record Publish Date
October 04, 2022
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 | 89 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 411 |
| U | Unclassified | 1 |