NeoConnect Fill Cap Coupler - NeoConnect Fill Cap Coupler - NEOMED, INC.

Duns Number:799772079

Device Description: NeoConnect Fill Cap Coupler

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More Product Details

Catalog Number

PC-EONC

Brand Name

NeoConnect Fill Cap Coupler

Version/Model Number

PC-EONC

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"

-

For Single-Use

Yes

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

KYX

Product Code Name

Dispenser, Liquid Medication

Device Record Status

Public Device Record Key

31a0f28c-d633-481d-a9aa-ca20ab4d2d02

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 10, 2017

Additional Identifiers

Package DI Number

20817584013111

Quantity per Package

16

Contains DI Package

10817584013114

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