Catalog Number

-

Brand Name

Codan

Version/Model Number

C 350N

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

8fa5b146-f4c0-4160-8ca1-7d35bdf587f4

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 30, 2017

Package DI Number

00813153020340

Quantity per Package

1

Contains DI Package

10813153020347

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-