Duns Number:799772079
Device Description: PUR Enteral Feeding Tube with ENFit Connector, Purple 8Fr X 105cm
Catalog Number
PFTXL8.0P-NC
Brand Name
NeoConnect Enteral Feeding Tube
Version/Model Number
PFTXL8.0P-NC
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
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
BSS
Product Code Name
Tube, Nasogastric
Public Device Record Key
823f9c93-eb30-402b-aa41-fcb7632068cf
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 19, 2016
Package DI Number
20817584011780
Quantity per Package
16
Contains DI Package
10817584011783
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 |