GUDID 00613994334565

CABLE 68005YN EGM 18L

MEDTRONIC, INC.

Cardiac radio-frequency ablation system generator

• Primary Device ID: 00613994334565
• NIH Device Record Key: f7e8cb89-2f9d-4be8-b310-c10e1dc18c5a
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 68005YN
• 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: false
• 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: false
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Length: 457 Centimeter
• Length: 457 Centimeter
• Length: 457 Centimeter
• Length: 457 Centimeter
• Length: 457 Centimeter
• Length: 457 Centimeter
• Length: 457 Centimeter
• Length: 457 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not expose the cable to storage temperatures above 65°C or below -35°C.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose the cable to storage temperatures above 65°C or below -35°C.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose the cable to storage temperatures above 65°C or below -35°C.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose the cable to storage temperatures above 65°C or below -35°C.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose the cable to storage temperatures above 65°C or below -35°C.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose the cable to storage temperatures above 65°C or below -35°C.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose the cable to storage temperatures above 65°C or below -35°C.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose the cable to storage temperatures above 65°C or below -35°C.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994334565 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060400

FDA Product Code

• OCL: Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-27
• Device Publish Date: 2016-05-02

Devices Manufactured by MEDTRONIC, INC.

• 00643169955653 - N'VISION®: 2024-10-14 SOFTWARE 8870AAV01 N'VISION US
• 00763000974732 - NA: 2024-10-14 CUSTOM PACK BB12H94R UNC 3/16 AV LP
• 00763000978297 - NA: 2024-10-14 CUSTOM PACK BB11F30R2 ADULTRES
• 00763000978303 - NA: 2024-10-14 CUSTOM PACK 3Y90R11 NURSES
• 00763000978426 - NA: 2024-10-14 CUSTOM PACK BB11C01R9 CHILD PACK
• 00763000978549 - NA: 2024-10-14 CUSTOM PACK BB12F68R6 SPECIALTY CAR
• 00763000978648 - NA: 2024-10-14 CUSTOM PACK BB2G71R11 ST. AGNES PK
• 00763000979119 - NA: 2024-10-14 CUSTOM PACK BB8P50R4 SUPPORT