AccessGUDID - DEVICE: Blazer® II (08714729199960)

GUDID

Device Identifier (DI) Information

Brand Name: Blazer® II
Version or Model: M0045031TMK20
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M0045031TMK20
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729199960
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Temperature Ablation Catheter

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:	Yes
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?
61785	Cardiac radio-frequency ablation system catheter	A sterile, flexible, steerable catheter intended to be used as part of a radio-frequency cardiac ablation system to apply radio-frequency alternating current to ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias; it is typically also intended to transmit electrical pacing stimuli to, and electrical responses from, the heart for electrophysiological (EP) mapping. It is intended to be introduced into the heart via venous access (e.g., femoral vein) and may contain monopolar and/or bipolar ablation electrodes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LPB	Cardiac ablation percutaneous catheter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P920047	000
P920047	001
P920047	002
P920047	003
P920047	004
P920047	006
P920047	007
P920047	008
P920047	009
P920047	010
P920047	012
P920047	015
P920047	017
P920047	018
P920047	019
P920047	021
P920047	023
P920047	024
P920047	026
P920047	027
P920047	028
P920047	030
P920047	031
P920047	035
P920047	036
P920047	037
P920047	039
P920047	040
P920047	045
P920047	047
P920047	048
P920047	049
P920047	060
P920047	063
P920047	071
P920047	072
P920047	073
P920047	076
P920047	080
P920047	092
P920047	098
P920047	116
P920047	124
P920047	133

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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
Device Size Text, specify: 7 F Diameter
Device Size Text, specify: 4 mm Length
Device Size Text, specify: 2.33 mm Diameter

Device Record Status

Public Device Record Key: db922dc7-5846-4774-8f00-3a2cca9f18d4
Public Version Date: September 10, 2024
Public Version Number: 6
DI Record Publish Date: September 24, 2014