DEVICE: SJM™ (05414734506441)

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Device Identifier (DI) Information

SJM™
4023
4023
ST. JUDE MEDICAL, INC.
05414734506441
GS1
1
ADAPTING SLEEVE KIT
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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
Pacing/defibrillation lead electrical adaptor A sterile implantable device designed to adapt the electrical connectors of an implanted pacemaker and/or defibrillator pacing lead to a non-compatible pacemaker or defibrillator (i.e., when they do not meet connection design). This device is implanted with the pacemaker or defibrillator system.
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FDA Product Code

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Product Code Product Code Name
DTD pacemaker lead Adaptor
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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
Storage Environment Temperature: between 23 and 122 Degrees Fahrenheit
Handling Environment Temperature: between 23 and 122 Degrees Fahrenheit
Handling Environment Temperature: between -5 and 50 Degrees Celsius
Storage Environment Temperature: between -5 and 50 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Length: 3.2 Millimeter
Length: 5 Millimeter
Outer Diameter: 6 Millimeter
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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)

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

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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