DEVICE: Pacel™ (05414734001137)

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Device Identifier (DI) Information

Pacel™
401771
401771
ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
05414734001137
GS1
1
No description.
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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
Temporary cardiac pacing catheter A sterile, flexible tube designed to deliver temporary pacing stimuli to the heart; it may detect bioelectric signals from the heart. It is used in the atria and/or ventricles and has electrodes which are usually applied to the ventricles and connect to an external pacemaker which generates the electrical pacing impulses. It may be unipolar or bipolar and facilitates the display of the electrocardiographic signal. It is used: 1) in an emergency during bradycardia or asystole until a pacemaker can be implanted to control the heart rate; 2) during and/or after surgery; or 3) during cardiac catheterization [e.g., electrophysiological (EP) examinations]. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
LDF ELECTRODE, PACEMAKER, TEMPORARY
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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
Special Storage Condition, Specify: Store in cool, dark, dry place. Keep dry and keep away from sunlight.
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Clinically Relevant Size

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Size Type Text
Catheter Gauge: 6 French
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Device Status

In Commercial Distribution
July 31, 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
15414734001134 5 05414734001137 In Commercial Distribution
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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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