DEVICE: Identity® (05414734006804)

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Device Identifier (DI) Information

Identity®
ADx SR
5180
ST. JUDE MEDICAL, INC.
05414734006804
GS1
1
No description.
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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
Single-chamber implantable pacemaker, rate-responsive A sterile, battery-powered device consisting of a hermetically-sealed pulse generator, implanted beneath the skin of the chest in a surgically-created pocket, with a pacing lead in or on one chamber of the heart (right atrium or ventricle). It is intended to generate and conduct electrical impulses to an abnormal heart to adjust its 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 to provide defibrillation therapy.
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FDA Product Code

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Product Code Product Code Name
KRG Programmer, pacemaker
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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 23 and 122 Degrees Fahrenheit
Storage Environment Temperature: between -5 and 50 Degrees Celsius
Storage Environment Temperature: between 23 and 122 Degrees Fahrenheit
Handling Environment Temperature: between -5 and 50 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 7.9 Milliliter
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Device Status

In Commercial Distribution
October 23, 2014

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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
HIBCC H758518006
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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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
Yes
Yes
No CLOSE

Customer Contact

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