RHYTHMIA HDx™

GUDID 08714729948360

ECG OUT Box

BOSTON SCIENTIFIC CORPORATION

Cardiac mapping system

• Primary Device ID: 08714729948360
• NIH Device Record Key: 54313f5f-30d0-495a-b14c-7ab346a93294
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RHYTHMIA HDx™
• Version Model Number: M004RH14010
• 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: false
• Serial Number: true
• 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	08714729948360 [Primary]

FDA Product Code

• DSA: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

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: 2020-10-20
• Device Publish Date: 2017-05-01

On-Brand Devices [RHYTHMIA HDx™]

• 08714729986003: Ablation Connection Box (SmartAblate)
• 08714729985983: Ablation Connection Box (IBI/Ampere)
• 08714729994077: Mapping System
• 08714729948377: ECG OUT Box
• 08714729948360: ECG OUT Box
• 08714729965879: Signal Station
• 08714729965862: Signal Station
• 08714729948407: Workstation PC
• 08714729938712: Signal Station
• 08714729938736: Localization Generator
• 00191506034429: Ablation Connection Box