Duns Number:799772079
Device Description: NeoConnect 60" (152 cm) Enteral Extension Set with ENFit Connector, Orange
Catalog Number
EXT-60NC
Brand Name
NeoConnect Enteral Extension Set
Version/Model Number
EXT-60NC
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
b3b6cbb1-d41d-4824-9867-bae5cd6191c9
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 19, 2016
Package DI Number
20817584012015
Quantity per Package
8
Contains DI Package
10817584012018
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 183 |