DEVICE: Model 6653 (04035479143541)

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Device Identifier (DI) Information

Model 6653
405231
405231
BIOTRONIK SE & Co. KG
04035479143541
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
Temporary cardiac pacing/stimulation connection cable, reusable A flexible wire, insulated with non-conductive material except at its ends, that provides a connection between an external temporary pacemaker and implanted cardiac pacing leads, to transmit electrical impulses to the heart and possibly relay information about the heart's activity back to the pacemaker. The proximal end plugs into a temporary pacemaker or an adaptor (e.g., when the cable/lead does not meet original design), and the distal end, which may consist of a connector block to accommodate different connection configurations, connects to the pacing leads/heart wires (e.g., IS-1 leads). This is a reusable device intended to be sterilized prior to use.
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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

Yes
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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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 0 and 50 Degrees Celsius
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Temperature: between 32 and 122 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
October 01, 2015

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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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Yes
No
Yes
No
No CLOSE

Customer Contact

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