Freezor® MAX

GUDID 00643169504905

CATHETER 239F3 FREEZOR MAX3 MED BLUE 9F

MEDTRONIC, INC.

Cardiac cryosurgical system catheter

• Primary Device ID: 00643169504905
• NIH Device Record Key: 0d8566d8-9d19-44f9-86c4-bbc76aa20969
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Freezor® MAX
• Version Model Number: 239F3
• 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

• Handling Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Handling Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Handling Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Handling Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Handling Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Handling Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Handling Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Handling Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169504905 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P100010

FDA Product Code

• OAE: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

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® MAX]

• 00613994804273: CATHETER 239F3 FREEZOR MAX3 MED BLUE 9F
• 00643169023505: CATH 229F3 FREEZOR MAX3 SURGICAL MED 9F
• 00643169023499: CATH 229F5 FREEZOR MAX5 SURGICAL LG 9F
• 00643169023482: CATHETER 239F3 FREEZOR MAX3 MED BLUE 9F
• 00643169023475: CATHETER 239F5 FREEZOR MAX5 LG ORANGE9F
• 00643169504929: CATH 229F3 FREEZOR MAX3 SURGICAL MED 9F
• 00643169504912: CATH 229F5 FREEZOR MAX5 SURGICAL LG 9F
• 00643169504905: CATHETER 239F3 FREEZOR MAX3 MED BLUE 9F
• 00643169504899: CATHETER 239F5 FREEZOR MAX5 LG ORANGE9F
• 00643169450387: CATHETER 239F5 FREEZOR MAX5 LG ORANGE9F
• 00643169450370: CATHETER 239F3 FREEZOR MAX3 MED BLUE 9F
• 00643169450363: CATH 229F5 FREEZOR MAX5 SURGICAL LG 9F
• 00643169450356: CATH 229F3 FREEZOR MAX3 SURGICAL MED 9F
• 00763000245474: CATHETER 239F3 FREEZOR MAX3 MED BLUE 9F
• 00763000245481: CATHETER 239F5 FREEZOR MAX5 LG ORANGE9F