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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: BK-IS4/DF4; BSDF-1; COV; D-KIT; D2-KIT; DF1-C6HV; DH DF4; EFH; ICS 3000; IS1-C5PS; Kainox VCS; Linox; Linoxsmart; PA-10; PA-11; PA-4; PK-44; Protego; PSW 1301.U; Renamic; S 60; S-65; S-75; Si-2; SI-8; TW; Vigila; VL; Volta
Classification Name: PROGRAMMER, PACEMAKER
Product Code: KRG
Device Class: 3
Regulation Number: 870.3700
Medical Specialty: Cardiovascular
Registered Establishment Name: BIOTRONIK, INC.
Registered Establishment Number: 1028232
Owner/Operator: BIOTRONIK, INC.
Owner/Operator Number: 1028232
Establishment Operations: Repackager/Relabeler