Alair™

FDA UDI

Class III (US FDA UDI)

by Boston Scientific

Identity

Trade Name: ALAIR™ FDA UDI
Generic Name: Radio-frequency ablation system FDA UDI
Device Name: Bronchial Thermoplasty Catheter FDA UDI
Model / Reference: M005ATS25010 FDA UDI
Description: Bronchial Thermoplasty Catheter FDA UDI

Identifiers

Catalog Number: M005ATS25010 FDA UDI
Primary DI / UDI-DI: 08714729802792 FDA UDI
PMA Number: P080032 FDA UDI
FDA Product Code: OOY FDA UDI
GMDN Term: Radio-frequency ablation system FDA UDI

Classification

Device Class: Class III FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Category: Radio-frequency ablation system

Alair™ by Boston Scientific — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radio-frequency ablation system.

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DIAMOND TIP — Jeisys Medical Inc. · Class IIb
Dophi — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Class II

Cleared under the same submission

P080032 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class III	Pending data

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Manufacturer

Manufacturer: Boston Scientific

Sources (1)

FDA UDI cf1aa744-3298-40a4-b685-e7c3f960f47c 36 fields · synced May 30, 2026