Freezor® Xtra

Basic Information

• Brand Name: Freezor® Xtra
• Primary DI: 00643169672475
• Version / Model: 227F3
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-16
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 7f47f381-1290-4942-8233-3d82a61f5bd2

Device Description

CATHETER 227F3 FREEZOR XTRA3 MED7F

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LPB	Cardiac ablation percutaneous catheter	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
60720	Cardiac cryosurgical system catheter	A sterile, flexible device intended to be used as part of a cardiac tissue cryosurgical system to cryogenically ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias. It is intended to be introduced into the heart via venous access (e.g., femoral vein) and deliver pressurized liquid refrigerant (e.g., nitrous oxide) to its distal cooling segment to achieve extremely low temperatures through gas expansion; it typically includes sensors (e.g., temperature monitoring). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00643169672475	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P020045	073

Device Sizes

Type	Value	Unit	Text
Length	108.0	Centimeter
Device Size Text, specify			catheter tip length 6mm
Catheter Gauge	7.0	French
Device Size Text, specify			catheter curve 55mm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Fragile handle with care
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Storage Environment Humidity
• Temperature Range: – 85 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -35 – 58 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: – 85 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius