AccessGUDID - DEVICE: Alair Bronchial Thermoplasty RF Controller (08714729796695)

GUDID

Device Identifier (DI) Information

Brand Name: Alair Bronchial Thermoplasty RF Controller
Version or Model: ATS 200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M005ATS20000
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729796695
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Alair BT Controller

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
OOY	Bronchial thermoplasty system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P080032	000
P080032	015
P080032	016

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 95016b7d-9f7d-4ae3-92ac-fc11db355fec
Public Version Date: January 18, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2014