DEVICE: SJM™ (05414734502375)

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Device Identifier (DI) Information

SJM™
FL-1056
FL-1056
ST. JUDE MEDICAL, INC.
05414734502375
GS1
1
FLUSHING TOOL
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Pacing lead implantation adaptor A small, sterile device intended to be connected to the proximal end of a compatible cardiac pacing lead containing a lumen for over-guidewire implantation, to enable flushing of the lumen (typically with heparinized saline) and aid insertion of a guidewire during implantation. The distal end of the device is intended to connect to the pacing lead; the proximal end is intended to act as both a Luer connector, for attachment of a syringe, and a wire guide for guidewire insertion; it is not intended to be implanted. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
NIK Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
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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
Handling Environment Temperature: between 23 and 122 Degrees Fahrenheit
Storage Environment Temperature: between -5 and 50 Degrees Celsius
Handling Environment Temperature: between -5 and 50 Degrees Celsius
Storage Environment Temperature: between 23 and 122 Degrees Fahrenheit
Special Storage Condition, Specify: Do not use if package is damaged.
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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
May 25, 2016

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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
Yes
No CLOSE

Customer Contact

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