Alair™ M005ATS20110

GUDID 08714729802778

RF Controller Accessory Kit

BOSTON SCIENTIFIC CORPORATION

Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system

• Primary Device ID: 08714729802778
• NIH Device Record Key: eb823c18-bf1b-4784-aaf9-1b374327f6f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alair™
• Version Model Number: M005ATS20110
• Catalog Number: M005ATS20110
• 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: true
• 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	08714729802778 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P080032

FDA Product Code

• OOY: Bronchial thermoplasty system

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-01-18
• Device Publish Date: 2014-09-24

On-Brand Devices [Alair™]

• 08714729802792: Bronchial Thermoplasty Catheter
• 08714729802778: RF Controller Accessory Kit