RHYTHMIA HDx™ M004RA6301US0

GUDID 00191506034429

Ablation Connection Box

BOSTON SCIENTIFIC CORPORATION

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
• 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)
• 08714729966326: Ablation Connection Box (Maestro™)
• 00191506020804: Ablation Connection Box (for INTELLAGEN™)
• 00191506020798: Ablation Connection Box - IntellaNav StablePoint™ (for INTELLAGEN™)
• 08714729972679: Localization Generator
• 08714729971306: EGM Out to Signal Station Cable (IBI™)
• 08714729971290: EGM Out to Signal Station Cable (Stockert™)
• 08714729960096: Mapping System
• 08714729948391: 72 Intracardiac Out Cable
• 08714729948384: Foot Switch
• 08714729948322: Breakout Box
• 08714729938729: Breakout Box Cable
• 08714729938682: Mapping System
• 08714729938668: Stimulator Jumper Cable
• 08714729938651: Patch Cable
• 08714729938644: CardioLab™ Direct Connect IC
• 08714729938637: CardioLab™ Direct Connect IC
• 08714729938606: Clearsign™ Direct Connect IC Orion™
• 08714729938590: Clearsign™ Direct Connect IC Orion™
• 08714729938583: Clearsign™ Direct Connect IC A/B
• 08714729938576: Clearsign™ Direct Connect IC A/B
• 08714729938545: Localization Generator Cable