RHYTHMIA HDx™

GUDID 08714729938538

ECG IN Cable (Limb and Chest)

BOSTON SCIENTIFIC CORPORATION

Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable

• Primary Device ID: 08714729938538
• NIH Device Record Key: 278085d4-f223-46b7-a09e-b7bbbc5fccc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RHYTHMIA HDx™
• Version Model Number: M004RA5110I0
• 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	08714729938538 [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: 2024-06-06
• 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
• 08714729938620: CardioLab™ Direct Connect ECG
• 08714729938613: CardioLab™ Direct Connect ECG
• 08714729938569: Clearsign™ Direct Connect ECG
• 08714729938552: Clearsign™ Direct Connect ECG
• 08714729938538: ECG IN Cable (Limb and Chest)
• 08714729938521: ECG IN Cable (Limb and Chest)
• 08714729938514: ECG IN Cable (Trunk)
• 08714729938507: ECG IN Cable (Trunk)