QUADRA ASSURA MP™ - Cardiac resynchronization device, tiered-therapy - ST. JUDE MEDICAL, INC.

Duns Number:790268031

Device Description: Cardiac resynchronization device, tiered-therapy cardioverter/defibrillator VVED DDDRV

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More Product Details

Catalog Number

CD3269-40

Brand Name

QUADRA ASSURA MP™

Version/Model Number

CD3269-40

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

-

Product Code Details

Product Code

NIK

Product Code Name

Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Device Record Status

Public Device Record Key

cd9db6c3-5f19-4e79-ad51-31a74de5c7f9

Public Version Date

February 05, 2021

Public Version Number

6

DI Record Publish Date

March 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ST. JUDE MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 70
2 A medical device with a moderate to high risk that requires special controls. 1429
3 A medical device with high risk that requires premarket approval 736