Duns Number:799772079
Device Description: 100mL GravityPro Enteral Syringe with ENFit Connector, Sterile, Purple
Catalog Number
PNM-S100NCV
Brand Name
NeoConnect GravityPro
Version/Model Number
PNM-S100NCV
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
PNR
Product Code Name
Enteral Syringes With Enteral Specific Connectors
Public Device Record Key
ee1594ae-99c4-4045-939f-fbc8e56b831d
Public Version Date
October 29, 2021
Public Version Number
6
DI Record Publish Date
September 19, 2016
Package DI Number
10817584012162
Quantity per Package
40
Contains DI Package
00817584012165
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |