NeoConnect Oral / Enteral Syringe, OTC - 3mL NeoConnect Enteral Syringe with ENFit - NEOMED, INC.

Duns Number:799772079

Device Description: 3mL NeoConnect Enteral Syringe with ENFit Connector, Non-Sterile, OTC

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More Product Details

Catalog Number

Neo3

Brand Name

NeoConnect Oral / Enteral Syringe, OTC

Version/Model Number

Neo3

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

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

3b6c2085-f5b4-4ef9-a8e5-7e03146b2f34

Public Version Date

October 29, 2021

Public Version Number

3

DI Record Publish Date

September 06, 2019

Additional Identifiers

Package DI Number

20817584013203

Quantity per Package

16

Contains DI Package

10817584013206

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper

"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