INFINITI - CP INF 5 JR4, JL3.5, PIG 145, - CORDIS CORPORATION

Duns Number:806136177

Device Description: CP INF 5 JR4, JL3.5, PIG 145,

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More Product Details

Catalog Number

CP0429

Brand Name

INFINITI

Version/Model Number

CP0429

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"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K970854,K970854

Product Code Details

Product Code

DQO

Product Code Name

CATHETER, INTRAVASCULAR, DIAGNOSTIC

Device Record Status

Public Device Record Key

acb5cb1d-b131-43c4-b996-4c49dda4619d

Public Version Date

September 14, 2022

Public Version Number

5

DI Record Publish Date

August 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CORDIS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2567
3 A medical device with high risk that requires premarket approval 204