Alair Bronchial Thermoplasty RF Controller M005ATS20000

GUDID 08714729796695

Alair BT Controller

BOSTON SCIENTIFIC CORPORATION

Radio-frequency ablation system

• Primary Device ID: 08714729796695
• NIH Device Record Key: 95016b7d-9f7d-4ae3-92ac-fc11db355fec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alair Bronchial Thermoplasty RF Controller
• Version Model Number: ATS 200
• Catalog Number: M005ATS20000
• 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	08714729796695 [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: 5
• Public Version Date: 2021-01-18
• Device Publish Date: 2014-09-24

On-Brand Devices [Alair Bronchial Thermoplasty RF Controller]

• 08714729961154: Alair BT Controller - ROHS Refurbished
• 08714729802822: Alair BT Controller - Refurbished
• 08714729796695: Alair BT Controller