Duns Number:799772079
Device Description: NeoConnect NeoSecure Tip Cap, Sterile, Purple
Catalog Number
PNM-TCNC
Brand Name
NeoConnect Syringe Tip Cap
Version/Model Number
PNM-TCNC
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
PIF
Product Code Name
Gastrointestinal Tubes With Enteral Specific Connectors
Public Device Record Key
e442c6e7-bdc4-41a2-b013-a6babe9e5f54
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 19, 2016
Package DI Number
20817584010967
Quantity per Package
16
Contains DI Package
10817584010960
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 |