Catalog Number

-

Brand Name

Codan

Version/Model Number

C 350-MP

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

b59b3869-8ecd-495d-af3c-dfb6e3f9cd2f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 28, 2017

Package DI Number

00813153020357

Quantity per Package

1

Contains DI Package

10813153020354

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-