Catalog Number

-

Brand Name

Codan

Version/Model Number

EF 122

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

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Public Device Record Key

e38f454c-7bdf-4582-bcd9-5a7996cb4a44

Public Version Date

January 30, 2020

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

00897891001168

Quantity per Package

1

Contains DI Package

10897891001165

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-