ALAIR™

Primary DI
08714729802792
Brand
ALAIR™
Company
BOSTON SCIENTIFIC CORPORATION
Model
M005ATS25010
Catalog number
M005ATS25010
Device description
Bronchial Thermoplasty Catheter
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
P080032004
P080032010
P080032012

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P080032000ALAIR BRONCHIAL THERMOPLASTY SYSTEMBoston Scientific Corp2010-04-27OOY
P080032004ALAIR BRONCHIAL THERMOPLASTY SYSTEMBoston Scientific Corp2010-04-27OOY
P080032010ALAIR BRONCHIAL THERMOPLASTY SYSTEMBoston Scientific Corp2010-04-27OOY
P080032012ALAIR BRONCHIAL THERMOPLASTY SYSTEMBoston Scientific Corp2010-04-27OOY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729802792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729802792087147298027928714729802792

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).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
021717889
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506062514Navigator™M0062504000M00625040002026-09-25
00191506062521Navigator™M0062504010M00625040102026-09-25
00191506062538Navigator™M0062504020M00625040202026-09-25
00191506062545Navigator™M0062504100M00625041002026-09-25
00191506062552Navigator™M0062504110M00625041102026-09-25
00191506062569Navigator™M0062504120M00625041202026-09-25
00191506062576Navigator™M0062504200M00625042002026-09-25
00191506062583Navigator™M0062504210M00625042102026-09-25
00191506062590Navigator™M0062504220M00625042202026-09-25
00802526531101ENDOTAK RELIANCE® S013701372014-09-24
00802526531118ENDOTAK RELIANCE® S013801382014-09-24
00802526531125ENDOTAK RELIANCE®015701572014-09-24
00802526531132ENDOTAK RELIANCE®015801582014-09-24
00191506047832NAM001AJAEC0100M001AJAEC01002026-09-22
00191506063214OPAL HDx™M004OPAL11020M004OPAL110202026-09-20
08714729972860LumiCoil™M005538302018-02-15
08714729972884LumiCoil™M005538402018-02-15
08714729842088Rhythmia™ Mapping SystemM004RH200002017-06-14
08714729842095Rhythmia™ Mapping SystemM004RH210002017-06-14
08714729842101Rhythmia™ Mapping SystemM004RH220002017-06-14

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
08714729802822Alair Bronchial Thermoplasty RF ControllerBOSTON SCIENTIFIC CORPORATIONOOY2014-09-24