RHYTHMIA HDx™ M004RA6301US0

GUDID 00191506034429

Ablation Connection Box

BOSTON SCIENTIFIC CORPORATION

Cardiac mapping system Cardiac mapping system Cardiac mapping system Cardiac mapping system Cardiac mapping system Cardiac mapping system Cardiac mapping system Cardiac mapping system Cardiac mapping system Cardiac mapping system Cardiac mapping system

• Primary Device ID: 00191506034429
• NIH Device Record Key: cae0ccbf-5dd6-4768-bcdb-545fdefe7e0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RHYTHMIA HDx™
• Version Model Number: M004RA6301US0
• Catalog Number: M004RA6301US0
• 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	00191506034429 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150005

FDA Product Code

• OAD: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-11
• Device Publish Date: 2024-03-02

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