Catalog Number

PCO-FNC

Brand Name

NeoConnect Syringe-to-Syringe Coupler

Version/Model Number

PCO-FNC

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

KYX

Product Code Name

Dispenser, Liquid Medication

Public Device Record Key

d3f9c6e6-9854-4d42-9e16-91215b997c76

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 19, 2016

Package DI Number

20817584010561

Quantity per Package

16

Contains DI Package

10817584010564

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper