Supreme™ 401445

GUDID 05414734201391

ST. JUDE MEDICAL CARDIOVASCULAR DIVISION

Cardiac mapping/radio-frequency ablation catheter, single-use

• Primary Device ID: 05414734201391
• NIH Device Record Key: dc86762a-5360-45c9-8956-b6904d4a284f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Supreme™
• Version Model Number: DAO™
• Catalog Number: 401445
• Company DUNS: 040960379
• Company Name: ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
• 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: true
• Expiration Date: true
• 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(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Device Dimensions

• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE. Protect from radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.Protect from radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.Protect from radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.Protect from radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.Protect from radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.Protect from radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.Protect from radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.Protect from radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE.Protect from radioactive sources.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734201391 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K894500

FDA Product Code

• DRF: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

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: 2015-04-06

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