Catalog Number

-

Brand Name

Codan

Version/Model Number

C 368N

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LHI

Product Code Name

Set, I.V. Fluid Transfer

Public Device Record Key

48cf75f1-067a-4b86-8ed7-9acb26a391c8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 20, 2016

Package DI Number

897891001557

Quantity per Package

1

Contains DI Package

10897891001554

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-