DiamondTemp™ FASTR RF Generator

GUDID 00763000708917

GENERATOR CEDTG200 FASTR RF US

MEDTRONIC, INC.

Cardiac radio-frequency ablation system generator

• Primary Device ID: 00763000708917
• NIH Device Record Key: 385544f8-ca71-4cef-9339-6d54026b9e5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DiamondTemp™ FASTR RF Generator
• Version Model Number: CEDTG200
• 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: false
• Serial Number: true
• 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
• 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 *Do not stack more than 2 high
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not stack more than 2 high
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not stack more than 2 high
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not stack more than 2 high
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not stack more than 2 high
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not stack more than 2 high
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000708917 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P200028

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-23
• Device Publish Date: 2024-12-14

On-Brand Devices [DiamondTemp™ FASTR RF Generator]

• 00763000482190: GENERATOR CEDTG200 FASTR RF US
• 00763000687960: GENERATOR CEDTG200 FASTR RF US/CAN
• 00763000745516: GENERATOR CEDTG200 FASTR RF LOANER US
• 00763000708917: GENERATOR CEDTG200 FASTR RF US