Codan - 60 Drop IV Set with Check Valve, Injection Port, - CODAN US CORPORATION

Duns Number:058027475

Device Description: 60 Drop IV Set with Check Valve, Injection Port, Needlefree Valve, 4-way Stopcock & Spinlo 60 Drop IV Set with Check Valve, Injection Port, Needlefree Valve, 4-way Stopcock & Spinlock

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More Product Details

Catalog Number

-

Brand Name

Codan

Version/Model Number

C463

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

f09f2579-7323-442a-a073-0ac1fe9b57d9

Public Version Date

September 08, 2021

Public Version Number

1

DI Record Publish Date

August 31, 2021

Additional Identifiers

Package DI Number

00813153026885

Quantity per Package

1

Contains DI Package

10813153026882

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