CARDIOBLATE®

GUDID 00885074243092

ADAPTER 60884 DISP ELEC ADPTR 15 LANG

MEDTRONIC, INC.

Cardiac radio-frequency ablation system generator

• Primary Device ID: 00885074243092
• NIH Device Record Key: 92bf5d59-9695-41d2-a623-4439965edf2a
• Commercial Distribution Discontinuation: 2017-08-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CARDIOBLATE®
• Version Model Number: 60884
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Maximum storage temperature: 49°C.
• Special Storage Condition, Specify: Between 0 and 0 *Maximum storage temperature: 49°C.
• Special Storage Condition, Specify: Between 0 and 0 *Maximum storage temperature: 49°C.
• Special Storage Condition, Specify: Between 0 and 0 *Maximum storage temperature: 49°C.
• Special Storage Condition, Specify: Between 0 and 0 *Maximum storage temperature: 49°C.
• Special Storage Condition, Specify: Between 0 and 0 *Maximum storage temperature: 49°C.
• Special Storage Condition, Specify: Between 0 and 0 *Maximum storage temperature: 49°C.
• Special Storage Condition, Specify: Between 0 and 0 *Maximum storage temperature: 49°C.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885074243092 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043291

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

On-Brand Devices [CARDIOBLATE®]

• 00613994334558: ABLATION PEN 4920501 W/PACING SENSING EN
• 00613994299413: GENERATOR 6800001AM CARDIOBLATE EN
• 00643169121850: GENERATOR 6800001AMR CARDIOBLATE EN
• 00721902864292: ABLATION PEN 60814 CARDIOBLATE EN
• 00721902709340: ABLATION PEN 60813 CARDIOBLATE N-PMP
• 00885074359625: ABLATION SYSTEM 60842 CARDIOBLATE LP
• 00885074359618: CARDIOBLATE 60841 LP STANDALONE EN
• 00885074266077: CARDIOBLATE 60832 BP2 SYSTEM, EN
• 00885074266022: CARDIOBLATE 60831 BP2 DEVICE EN
• 00885074243092: ADAPTER 60884 DISP ELEC ADPTR 15 LANG