NeoConnect GravityPro - 20mL GravityPro Enteral Syringe with ENFit - NEOMED, INC.

Duns Number:799772079

Device Description: 20mL GravityPro Enteral Syringe with ENFit Connector, Sterile, Purple

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More Product Details

Catalog Number

PNM-S20NCV

Brand Name

NeoConnect GravityPro

Version/Model Number

PNM-S20NCV

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

PNR

Product Code Name

Enteral Syringes With Enteral Specific Connectors

Device Record Status

Public Device Record Key

95330ab6-2c60-4dca-b2e6-96ba10337855

Public Version Date

October 29, 2021

Public Version Number

6

DI Record Publish Date

September 19, 2016

Additional Identifiers

Package DI Number

10817584012179

Quantity per Package

100

Contains DI Package

00817584012172

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"NEOMED, INC." Characteristics
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