DEVICE: Model 3145 (04035479143190)

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Device Identifier (DI) Information

Model 3145
Refurbishment II
391500
BIOTRONIK SE & Co. KG
04035479143190
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
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
Implantable pacemaker analyser, intraoperative An electronic instrument designed to test an implanted cardiac pacemaker, including the lead/tissue interface at the time of implantation, for invasive pacemaker evaluation and/or during electrophysiology (EP) diagnostic procedures. It has testing and recording capabilities to measure the minimum electrical stimulus needed to elicit ventricular contraction and the minimum intracardiac signal amplitude needed to inhibit the pacemaker (i.e., stimulation and sensing thresholds respectively). It typically includes measuring devices for the bioelectrical signals, a pulse generator, controllers, and the capability to test the characteristics and performance of the implanted pacemaker.
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FDA Product Code

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Product Code Product Code Name
OVJ Pulse generator, external pacemaker, dual-chamber
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Sterilization

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

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Storage and Handling
Special Storage Condition, Specify: Storage Environment Atmospheric Pressure 7-15 psi
Storage Environment Temperature: between -20 and 70 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 25 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -4 and 158 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
August 21, 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
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
No
No
No CLOSE

Customer Contact

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+1(888)345-0374
jon.brumbaugh@biotronik.com
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