DEVICE: ALAIR™ (08714729802792)

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Device Record History
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Device Identifier (DI) Information
ALAIR™
M005ATS25010
In Commercial Distribution
M005ATS25010
BOSTON SCIENTIFIC CORPORATION
08714729802792
GS1

1
021717889 *Terms of Use
Bronchial Thermoplasty Catheter
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
57972 Radio-frequency ablation system
An assembly of devices designed to generate and apply radio-frequency (RF) electrical current for heating via an electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues, including nerves, tumours, precancerous tissue; it may be intended for coagulation however it is not intended for electrosurgical cutting. It typically includes a mains electricity (AC-powered) RF current generator, controls, cables, and an appropriate electrosurgical ablation probe, catheter, and/or handpiece with electrode(s).
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
OOY Bronchial thermoplasty system
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
P080032 000
P080032 004
P080032 010
P080032 012
No CLOSE

Sterilization
Yes
Yes
Sterilization Method [?]
Radiation Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 150 cm Length
Device Size Text, specify: 2.0 mm Diameter
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Device Record Status
cf1aa744-3298-40a4-b685-e7c3f960f47c
January 18, 2021
4
September 24, 2014
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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