Duns Number:799772079
Device Description: 6mL NeoConnect Enteral Syringe with ENFit Connector, Non-Sterile, OTC
Catalog Number
Neo6
Brand Name
NeoConnect Oral / Enteral Syringe, OTC
Version/Model Number
Neo6
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PNR
Product Code Name
Enteral Syringes With Enteral Specific Connectors
Public Device Record Key
40a6e4a2-c7a0-4a01-8d0b-a28d8a159c31
Public Version Date
October 29, 2021
Public Version Number
3
DI Record Publish Date
September 06, 2019
Package DI Number
20817584013210
Quantity per Package
16
Contains DI Package
10817584013213
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 |