SMARTFREEZE™

Basic Information

• Brand Name: SMARTFREEZE™
• Primary DI: 08714729992691
• Version / Model: M004CRBS4000
• Catalog Number: M004CRBS4000
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Labeler DUNS: 021717889
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-21
• Public Version: 1
• Public Version Date: 2023-08-29
• Public Version Status: New
• Public Device Record Key: 9166a198-aed1-4194-bfe3-64ac90311b58

Device Description

Cryo-Console

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OAE	Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
60721	Cardiac cryosurgical system	A mobile assembly of mains electricity (AC-powered) devices intended to cryogenically ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias. It typically includes a console, monitor, connection cable(s), electrocardiogram (ECG) electrodes, and a cryoablation catheter in which extremely low temperatures are achieved through expansion of a pressurized liquid refrigerant (e.g., nitrous oxide) at the catheter tip; monitoring is achieved via ECG displays and sensors within the catheter.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08714729992691	GS1

Premarket Submissions

Submission Number	Supplement Number
P220032	000