ALAIR™ M005ATS25010

GUDID 08714729802792

Bronchial Thermoplasty Catheter

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: 08714729802792
• NIH Device Record Key: cf1aa744-3298-40a4-b685-e7c3f960f47c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALAIR™
• Version Model Number: M005ATS25010
• Catalog Number: M005ATS25010
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729802792 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P080032

FDA Product Code

• OOY: Bronchial thermoplasty system

Sterilization

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

[08714729802792]

Radiation Sterilization

[08714729802792]

Radiation Sterilization

[08714729802792]

Radiation Sterilization

[08714729802792]

Radiation Sterilization

[08714729802792]

Radiation Sterilization

[08714729802792]

Radiation Sterilization

[08714729802792]

Radiation Sterilization

[08714729802792]

Radiation Sterilization

[08714729802792]

Radiation Sterilization

[08714729802792]

Radiation Sterilization

[08714729802792]

Radiation Sterilization

[08714729802792]

Radiation Sterilization

[08714729802792]

Radiation Sterilization

[08714729802792]

Radiation Sterilization

[08714729802792]

Radiation Sterilization

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