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
08714729142201EndoVive Low Profile Replacement ButtonM005627702016-09-24
08714729142218EndoVive Low Profile Replacement ButtonM005628302016-09-24
08714729149200EndoVive™ One Step Button™M00568450M005684502018-09-07
08714729149217EndoVive™ One Step Button™M00568470M005684702018-09-07
08714729149224EndoVive™ One Step Button™M00568500M005685002018-09-07
08714729149231EndoVive™ One Step Button™M00568520M005685202018-09-07
08714729149934EndoVive™ One Step Button™M00568480M005684802018-09-07
08714729149941EndoVive™ One Step Button™M00568530M005685302018-09-07
08714729150084EndoVive™ One Step Button™M00568460M005684602018-09-07
08714729151081EndoVive™ One Step Button™M00568510M005685102018-09-07
08714729284017EndoVive Low Profile Replacement ButtonM005627602016-09-24
08714729284024EndoVive Low Profile Replacement ButtonM005627802016-09-24
08714729284031EndoVive Low Profile Replacement ButtonM005627902016-09-24
08714729284048EndoVive Low Profile Replacement ButtonM005628002016-09-24
08714729284062EndoVive Low Profile Replacement ButtonM005628202016-09-24
08714729284079EndoVive Low Profile Replacement ButtonM005628402016-09-24
08714729284086EndoVive Low Profile Replacement ButtonM005628502016-09-24
08714729821717Radial Jaw 4M005151802016-09-24
08714729821731Radial Jaw 4M005151902016-09-24
08714729821748Radial Jaw 4M005152002016-09-24

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