Celsius

Basic Information

• Brand Name: Celsius
• Primary DI: 10846835005455
• Version / Model: D7BTGL
• Catalog Number: D7BTGL
• Company Name: Biosense Webster Inc
• Labeler DUNS: 020163218
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-10
• Public Version: 6
• Public Version Date: 2022-06-07
• Public Version Status: Update
• Public Device Record Key: 69dc5de4-b505-4ecc-8fa5-7df89162b394

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRF	CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING	Cardiovascular	870.1220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10846835005455	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P950005	002

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if package is opened
• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if package is damaged
• Type: Special Storage Condition, Specify
• Special Conditions: Keep out of direct sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry