Duns Number:799772079
Device Description: NeoConnect DoseMate, Oral Administration Tip, Sterile, Purple
Catalog Number
POA-TNC
Brand Name
NeoConnect Oral Administration Tip
Version/Model Number
POA-TNC
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"
-
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
KYX
Product Code Name
Dispenser, Liquid Medication
Public Device Record Key
289ce20f-0dbc-499f-be05-9f9dcd6f4876
Public Version Date
October 29, 2021
Public Version Number
3
DI Record Publish Date
September 19, 2016
Package DI Number
20817584011032
Quantity per Package
16
Contains DI Package
10817584011035
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 |