CODAN - Multiport Extension Set - CODAN US CORPORATION

Duns Number:058027475

Device Description: Multiport Extension Set

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More Product Details

Catalog Number

-

Brand Name

CODAN

Version/Model Number

BC 2097

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Device Record Status

Public Device Record Key

2f16a0c5-3536-4d11-98b9-5945d47f4c53

Public Version Date

March 09, 2020

Public Version Number

1

DI Record Publish Date

February 29, 2020

Additional Identifiers

Package DI Number

00813153025895

Quantity per Package

1

Contains DI Package

10813153025892

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"CODAN US CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 381