DEVICE: SJM™ (05414734500029)

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Device Identifier (DI) Information

SJM™
AC-0130
AC-0130
ST. JUDE MEDICAL, INC.
05414734500029
GS1
1
SILICONE OIL
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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
Implantable-device lubricant A sterile, friction-reducing substance (e.g., mineral oil) that is primarily used on implantable devices prior to implantation to lubricate surfaces for the promotion of effective function. It is typically used on the pacing leads of implantable pacemakers/defibrillators to lubricate the lead terminal pin to ease its insertion into the header connector (connection socket) of a pulse generator where it is locked into place (some leads have seal rings on the terminal pin which create friction). It is typically supplied in a small disposable tube. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
LWS Implantable cardioverter defibrillator (non-CRT)
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 32 and 104 Degrees Fahrenheit
Storage Environment Temperature: between 0 and 40 Degrees Celsius
Handling Environment Temperature: between 32 and 104 Degrees Fahrenheit
Handling Environment Temperature: between 0 and 40 Degrees Celsius
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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
February 06, 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

[?]
Issuing Agency [?] Secondary DI Number
HIBCC H758AC01300
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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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

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