AccessGUDID - DEVICE: Blazer® II XP (08714729452348)

GUDID

Device Identifier (DI) Information

Brand Name: Blazer® II XP
Version or Model: M0044770THM0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M0044770THM0
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729452348
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
OAD	catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P020025	000
P020025	001
P020025	002
P020025	004
P020025	005
P020025	006
P020025	010
P020025	011
P020025	012
P020025	014
P020025	015
P020025	018
P020025	019
P020025	020
P020025	021
P020025	026
P020025	028
P020025	029
P020025	031
P020025	044
P020025	049
P020025	059
P020025	060
P020025	061
P020025	067
P020025	088
P020025	101
P020025	120
P020025	129
P020025	141

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: 8 F Diameter
Device Size Text, specify: 2.67 mm Diameter
Device Size Text, specify: 8 mm Length

Device Record Status

Public Device Record Key: a9898e93-56fe-4c4c-82ab-1f209972635b
Public Version Date: September 10, 2024
Public Version Number: 6
DI Record Publish Date: September 24, 2014