Rhythmia™ Mapping System

GUDID 08714729842101

Sensor Interface Unit (SIU)

BOSTON SCIENTIFIC CORPORATION

Electromagnetic surgical navigation device tracking system

• Primary Device ID: 08714729842101
• NIH Device Record Key: e4740b55-d33b-44da-9295-fc8d4fab0e40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rhythmia™ Mapping System
• Version Model Number: M004RH22000
• Company DUNS: 021717889
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729842101 [Primary]

FDA Product Code

• DQK: COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-09-18
• Device Publish Date: 2017-06-14

On-Brand Devices [Rhythmia™ Mapping System]

• 08714729841906: Rhythmia Power Supply
• 08714729880318: Magnetic Tracking System Kit
• 08714729842101: Sensor Interface Unit (SIU)
• 08714729842095: System Control Unit (SCU)
• 08714729842088: Localization Generator
• 08714729841739: ECG Cable - Chest - US AAMI
• 08714729841715: ECG Cable - Limbs - US AAMI
• 08714729841692: ECG Cable - Trunk - US AAMI