DEVICE: Quickflex™ (05414734502603)

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Device Identifier (DI) Information

Quickflex™
µ
1258T-75
ST. JUDE MEDICAL, INC.
05414734502603
GS1
1
Left heart lead
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
Yes
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Endocardial pacing lead A sterile, implantable flexible wire with an electrode, insulated with non-conductive material except at its ends, which serves as an electrical conductor to transmit pacing impulses from an implanted pulse generator to the heart; it is not intended to conduct defibrillation impulses. It may also transmit electrical responses from the heart back to the pacemaker. The electrode end is normally placed through a vein to contact the wall of one of the heart's chambers (endocardium), and the other end is connected to the pacemaker. It is typically impregnated with a steroid (e.g., dexamethasone) intended to elute into the tissues to reduce inflammation.
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FDA Product Code

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Product Code Product Code Name
OJX Drug eluting permanent left ventricular (lv) pacemaker electrode
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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 -5 and 50 Degrees Celsius
Handling Environment Temperature: between 23 and 122 Degrees Fahrenheit
Handling Environment Temperature: between -5 and 50 Degrees Celsius
Storage Environment Temperature: between 23 and 122 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
Length: 75 Centimeter
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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)

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No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
Yes
Yes
No CLOSE

Customer Contact

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