Freezor®

GUDID 00643169504745

CATHETER 307F5 FREEZOR5 LONG ORANGE 7F

MEDTRONIC, INC.

Cardiac cryosurgical system catheter

• Primary Device ID: 00643169504745
• NIH Device Record Key: 76557b59-1db7-4b17-96ff-55dc4c48f342
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Freezor®
• Version Model Number: 307F5
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169504745 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P020045

FDA Product Code

• LPB: Cardiac ablation percutaneous catheter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-18

On-Brand Devices [Freezor®]

• 00643169023444: CATHETER 307F1 FREEZOR1 SHT RED 7F
• 00643169023437: CATHETER 307F3 FREEZOR3 MED BLUE 7F
• 00643169023420: CATHETER 307F5 FREEZOR5 LONG ORANGE 7F
• 00643169504769: CATHETER 307F1 FREEZOR1 SHT RED 7F
• 00643169504752: CATHETER 307F3 FREEZOR3 MED BLUE 7F
• 00643169504745: CATHETER 307F5 FREEZOR5 LONG ORANGE 7F
• 00643169450417: CATHETER 307F5 FREEZOR5 LONG ORANGE 7F
• 00643169450400: CATHETER 307F3 FREEZOR3 MED BLUE 7F
• 00643169450394: CATHETER 307F1 FREEZOR1 SHT RED 7F