AccessGUDID - DEVICE: Chilli II® (08714729452805)

GUDID

Device Identifier (DI) Information

Brand Name: Chilli II®
Version or Model: M00490310
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: M00490310
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729452805
Issuing Agency: GS1
Commercial Distribution End Date: December 16, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Cooled 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 [?]
P980003	000
P980003	001
P980003	002
P980003	004
P980003	005
P980003	007
P980003	008
P980003	009
P980003	010
P980003	013
P980003	015
P980003	016
P980003	018
P980003	019
P980003	020
P980003	021
P980003	025
P980003	027
P980003	030
P980003	031
P980003	034
P980003	038
P980003	041
P980003	045
P980003	050
P980003	052
P980003	053
P980003	056
P980003	061
P980003	074

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: 4 mm Length
Device Size Text, specify: 7.5 F Diameter
Device Size Text, specify: 2.50 mm Diameter

Device Record Status

Public Device Record Key: ad1a0432-e072-408b-a6ed-e6201a19769d
Public Version Date: July 11, 2024
Public Version Number: 4
DI Record Publish Date: September 24, 2014