DEVICE: Unify Assura™ (05414734505635)

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Device Identifier (DI) Information

Unify Assura™
CD3257-40Q
CD3257-40Q
ST. JUDE MEDICAL, INC.
05414734505635
GS1
1
Cardiac resynchronization device, tiered-therapy cardioverter/defibrillator VVED DDDRV
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
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No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Cardiac resynchronization therapy implantable defibrillator A sterile, 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)].
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FDA Product Code

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

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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

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Size Type Text
Total Volume: 36 Milliliter
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Device Status

In Commercial Distribution
February 03, 2017

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
Yes
Yes
No CLOSE

Customer Contact

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+1(855)478-5833
customerservice@sjm.com
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