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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: 2020A Cardiosight Reader; 2490C Carelink Monitor; 2490C LCM Carelink Monitor; 2490GHJ Carelink Monitor; MyCareLink Patient Monitor
Classification Name: PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS
Product Code: OSR
Device Class: 3
Registered Establishment Name: Plexus Manufacturing Sdn. Bhd.
Registered Establishment Number: 3004593495
Owner/Operator: PLEXUS CORP.
Owner/Operator Number: 3019588
Establishment Operations: Contract Manufacturer
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