RF ENHANCR® II

GUDID 00643169147942

CATH 31745533 RF ENHANCR II W/O CE

MEDTRONIC, INC.

Cardiac radio-frequency ablation system catheter

• Primary Device ID: 00643169147942
• NIH Device Record Key: 8f01cfcd-9e41-4275-bb8b-438873137b88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RF ENHANCR® II
• Version Model Number: 31745533
• 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
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169147942 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P930029

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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-23

On-Brand Devices [RF ENHANCR® II]

• 00643169147980: CATH 39746534 RF ENHANCR II W/O CE
• 00643169147966: CATH 39745533 RF ENHANCR II W/O CE
• 00643169147942: CATH 31745533 RF ENHANCR II W/O CE
• 00643169147928: CATH 31745523 RF ENHANCR II W/O CE
• 00643169147904: CATH 31744523 RF ENHANCR II W/O CE