DEVICE: Reocor S Redeladapter (04035479114343)

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Device Identifier (DI) Information

Reocor S Redeladapter
371263
371263
BIOTRONIK SE & Co. KG
04035479114343
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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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
External pacemaker, noninvasive A device that generates electrical cardiac pacing impulses from an external pulse generator (EPG), located outside the body, to stimulate the entire heart simultaneously (in contrast to single- or dual-chambered invasive pacing) to resuscitate the patient, restore normal cardiac rhythm, and/or temporarily pace the heart during invasive procedures that may induce cardiac arrhythmias or asystole (cardiac standstill). The electrical impulses from the device are usually applied to the surface of the chest through cutaneous leads/electrodes (transcutaneous cardiac stimulation), but may be transmitted directly to the heart through a connection with implanted leads.
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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
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Temperature: between 32 and 122 Degrees Fahrenheit
Storage Environment Temperature: between 0 and 50 Degrees Celsius
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
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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
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No CLOSE

Customer Contact

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