Alair Bronchial Thermoplasty RF Controller

Primary DI
08714729802822
Brand
Alair Bronchial Thermoplasty RF Controller
Company
BOSTON SCIENTIFIC CORPORATION
Model
ATS 200
Catalog number
M005ATS200R0
Device description
Alair BT Controller - Refurbished
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OOYBronchial thermoplasty system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOYBronchial Thermoplasty SystemUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P080032000
P080032015
P080032016

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P080032000ALAIR BRONCHIAL THERMOPLASTY SYSTEMBoston Scientific Corp2010-04-27OOY
P080032015ALAIR BRONCHIAL THERMOPLASTY SYSTEMBoston Scientific Corp2010-04-27OOY
P080032016ALAIR BRONCHIAL THERMOPLASTY SYSTEMBoston Scientific Corp2010-04-27OOY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729802822PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729802822087147298028228714729802822

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency ablation systemAn 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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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08714729893431ROTAPRO™ AdvancerH74939299A02018-07-11
08714729999560ROTAPRO™H749394671250H7493946712502020-07-01
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08714729999591ROTAPRO™H749394672000H7493946720002020-07-01
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08714729999614ROTAPRO™H749394672250H7493946722502020-07-01
08714729999621ROTAPRO™H749394672380H7493946723802020-07-01
08714729999638ROTAPRO™H749394672500H7493946725002020-07-01
00685447020677RFP-100A™ RF Puncture GeneratorM004RFP100A0M004RFP100A02026-06-08
00191506049232Orbera™M00505670M005056702026-06-04
08714729121190Ultraflex™ Esophageal NGM005142002015-09-24
08714729121206Ultraflex™ Esophageal NGM005142102015-09-24
08714729121213Ultraflex™ Esophageal NGM005142202015-09-24
08714729121220Ultraflex™ Esophageal NGM005142302015-09-24
08714729649113Ultraflex™ Esophageal NGM005137502015-09-24
08714729716075Ultraflex™ Esophageal NGM005138502015-09-24
08714729716082Ultraflex™ Esophageal NGM005138602015-09-24
08714729716099Ultraflex™ Esophageal NGM005138402015-09-24
08714729716105Ultraflex™ Esophageal NGM005142402015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08714729961154Alair Bronchial Thermoplasty RF ControllerBOSTON SCIENTIFIC CORPORATIONOOY2017-08-07
08714729796695Alair Bronchial Thermoplasty RF ControllerBOSTON SCIENTIFIC CORPORATIONOOY2014-09-24
08714729802778Alair™BOSTON SCIENTIFIC CORPORATIONOOY2014-09-24
08714729802792ALAIR™BOSTON SCIENTIFIC CORPORATIONOOY2014-09-24