AccessGUDID - DEVICE: Quadra Assura™ (05414734505673)

GUDID

Device Identifier (DI) Information

Brand Name: Quadra Assura™
Version or Model: CD3265-40Q
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CD3265-40Q
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05414734505673
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790268031 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47270	Cardiac resynchronization therapy implantable defibrillator	An implantable, battery-powered device consisting of a hermetically-sealed pacing pulse generator and an integrated defibrillation pulse generator with leads in the right ventricle, in a coronary vein over the left ventricle, and often in the right atrium (triple chamber). In addition to conventional pacing and defibrillation functions, the device is intended to provide cardiac resynchronization therapy (CRT) through biventricular electrical stimulation to synchronize right and left ventricular contractions for more effective blood pumping to treat symptoms of heart failure (e.g., shortness of breath, easy fatigue) and serious heart-rhythm problems [CRT defibrillator (CRT-D)].	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NIK	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Temperature: between 10 and 45 Degrees Celsius
Storage Environment Temperature: between 50 and 113 Degrees Fahrenheit
Special Storage Condition, Specify: Store the device in a clean area, away from magnets, kits containing magnets, and sources of electromagnetic interference.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 97acf10c-3f06-4978-a8bd-9d5ef761a4a0
Public Version Date: February 05, 2021
Public Version Number: 7
DI Record Publish Date: February 03, 2017