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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: SEDASYS Automated Response Monitor (ARM Handset); SEDASYS Bedside Monitoring Unit (BMU); SEDASYS Computer-Assisted Personal Sedation System; SEDASYS ECG Cable AAMI Color Std; SEDASYS ECG Leads AAMI Color Std; SEDASYS Procedure Room Unit (PRU); SEDASYS PRU 15" LCD Display; SEDASYS PRU Power Supply (PSU); SEDASYS Umbilical Cable - 8' PRU to BMU
Classification Name: COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM
Product Code: PDR
Device Class: 3
Registered Establishment Name: MACK MOLDING COMPANY
Registered Establishment Number: 3000236920
Owner/Operator: MACK MOLDING COMPANY
Owner/Operator Number: 9040779
Establishment Operations: Contract Manufacturer
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