Catalog Number

PI-ENC

Brand Name

NeoConnect Press-in Bottle Adapter

Version/Model Number

PI-ENC

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)

-

Over the Counter (OTC)

Yes

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

8a607cdf-2538-475d-829b-3f304a7377c6

Public Version Date

September 30, 2020

Public Version Number

1

DI Record Publish Date

September 22, 2020

Package DI Number

20817584013388

Quantity per Package

16

Contains DI Package

10817584013381

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper