Catalog Number

-

Brand Name

Codan

Version/Model Number

EF 132-OS

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

8bcc1fb9-0e29-48b7-b038-ad0b1de3af1e

Public Version Date

January 31, 2020

Public Version Number

3

DI Record Publish Date

March 31, 2017

Package DI Number

00897891001816

Quantity per Package

1

Contains DI Package

10897891001813

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-