DEVICE: Assurity™ (05414734507073)

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Device Identifier (DI) Information

Assurity™
DR
PM2240
ST. JUDE MEDICAL, INC.
05414734507073
GS1
1
Pulse Generator DDDR                                                      
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Dual-chamber implantable pacemaker, rate-responsive A sterile, battery-powered, hermetically-sealed pulse generator, implanted beneath the skin of the chest in a surgically-created pocket, with pacing leads in or on two chambers of the heart (right atrium and ventricle). It is intended to stimulate the chambers of an abnormal heart, through electrical impulses, to beat in their natural sequence, and to adjust the rate of contraction to meet the body's increased need for blood flow due to activity. It contains one or more sensors to detect changes in the body (e.g., motion, breathing frequency) to indicate more oxygen is needed, and subsequently increases the pacing rate; it is not intended for defibrillation therapy.
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FDA Product Code

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Product Code Product Code Name
NVZ Pulse generator, permanent, implantable
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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 -5 and 50 Degrees Celsius
Storage Environment Temperature: between 23 and 122 Degrees Fahrenheit
Handling Environment Temperature: between 23 and 122 Degrees Fahrenheit
Storage Environment Temperature: between -5 and 50 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Total Volume: 10.4 Milliliter
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Device Status

In Commercial Distribution
April 10, 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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