Arctic Front Advance™

GUDID 00643169753686

CATHETER 2AF234 ARCTIC FRONT ADV US 23MM

MEDTRONIC, INC.

Cardiac cryosurgical system catheter

• Primary Device ID: 00643169753686
• NIH Device Record Key: 23c8b682-0660-4a10-a004-850a2b542d59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arctic Front Advance™
• Version Model Number: 2AF234
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between -31 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -31 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -31 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -31 Degrees Fahrenheit and 113 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169753686 [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: 2016-09-09

On-Brand Devices [Arctic Front Advance™]

• 00643169939318: CATHETER 2AF284 ARCTIC FRONT ADV US 28MM
• 00643169939271: CATHETER 2AF234 ARCTIC FRONT ADV US 23MM
• 00643169753693: CATHETER 2AF284 ARCTIC FRONT ADV US 28MM
• 00643169753686: CATHETER 2AF234 ARCTIC FRONT ADV US 23MM
• 00643169504783: CATHETER 2AF284 ARCTIC FRONT ADV US 28MM
• 00643169345614: CATHETER 2AF284 AFA US 28MM
• 00643169345591: CATHETER 2AF234 AFA US 23MM
• 00643169976382: CATHETER 2AF284 ARCTIC FRONT ADV US 28MM
• 00643169976368: CATHETER 2AF234 ARCTIC FRONT ADV US 23MM
• 00643169878365: CATHETER 2AF284 ARCTIC FRONT ADV US 28MM
• 00643169878327: CATHETER 2AF234 ARCTIC FRONT ADV US 23MM
• 00763000341480: CATH 2AF284 ARCTIC FRONT ADV US 28MM MVC
• 00763000341473: CATH 2AF234 ARCTIC FRONT ADV US 23MM MVC
• 00763000431501: CATHETER 2AF284 ARCTIC FRONT ADV US 28MM
• 00763000431488: CATHETER 2AF234 ARCTIC FRONT ADV US 23MM
• 00763000431532: CATH 2AF284 ARCTIC FRONT ADV US 28MM MVC
• 00763000431518: CATH 2AF234 ARCTIC FRONT ADV US 23MM MVC