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
Primary DIBrandModelCatalogPublished
08714729832089Rubicon™ 18H749392390180902016-09-24
08714729832096Rubicon™ 35H749392400350902016-09-24
08714729832102Rubicon™ 35H749392400351502016-09-24
08714729832119Rubicon™ 35H749392400350602016-09-24
08714729832126Rubicon™ 35H749392400351302016-09-24
08714729832133Rubicon™ 14H749392120141302016-09-24
08714729832140Rubicon™ 14H749392120141502016-09-24
08714729832157Rubicon™ 18H749392390181302016-09-24
08714729832164Rubicon™ 18H749392390181502016-09-24
00191506019563Rubicon™ ControlH749394321409A0H749394321409A02024-02-16
00191506019587Rubicon™ ControlH749394321413A0H749394321413A02024-02-16
00191506019600Rubicon™ ControlH749394321415A0H749394321415A02024-02-16
00191506019624Rubicon™ ControlH749394321809A0H749394321809A02024-02-16
00191506019648Rubicon™ ControlH749394321813A0H749394321813A02024-02-16
00191506019662Rubicon™ ControlH749394321815A0H749394321815A02024-02-16
00191506019686Rubicon™ ControlH749394321815S0H749394321815S02024-02-16
00191506019709Rubicon™ ControlH749394323506A0H749394323506A02024-02-16
00191506019723Rubicon™ ControlH749394323506B0H749394323506B02024-02-16
00191506019747Rubicon™ ControlH749394323509A0H749394323509A02024-02-16
00191506019761Rubicon™ ControlH749394323509B0H749394323509B02024-02-16

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