Codan - I.V Filter Set (Non-Dehp) with 0.22 Micron Filter - CODAN US CORPORATION

Duns Number:058027475

Device Description: I.V Filter Set (Non-Dehp) with 0.22 Micron Filter & Luer Lock

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More Product Details

Catalog Number

-

Brand Name

Codan

Version/Model Number

BC 696

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

7ec6df6a-4c5e-46e2-89e1-b8e50e381e91

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 30, 2017

Additional Identifiers

Package DI Number

00897891001465

Quantity per Package

1

Contains DI Package

10897891001462

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