Supreme™ 401952

GUDID 05414734201766

ST. JUDE MEDICAL CARDIOVASCULAR DIVISION

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

• Primary Device ID: 05414734201766
• NIH Device Record Key: 2d42b7fc-07a7-4943-a43b-60edf2801291
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Supreme™
• Version Model Number: CRD™
• Catalog Number: 401952
• 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	05414734201766 [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: 2015-04-22

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• 05414734206716: 401984
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• 05414734206693: 401982
• 05414734206686: 401981
• 05414734206679: 401980
• 05414734202107: CSL™
• 05414734202084: CRD™
• 05414734202046: CRD-2™
• 05414734202039: CRD-2™
• 05414734202022: CRD-2™
• 05414734202015: CRD-2™
• 05414734202008: CRD-2™
• 05414734201995: CRD-2™
• 05414734201933: CRD™
• 05414734201919: JSN™
• 05414734201902: JSN™
• 05414734201896: CSL™
• 05414734201865: CRD-2™
• 05414734201858: CRD-2™
• 05414734201841: CRD-2™
• 05414734201810: CRD™
• 05414734201803: CRD™
• 05414734201766: CRD™
• 05414734201759: JSN™
• 05414734201698: CSL™
• 05414734201681: DAO™
• 05414734201674: CRD™
• 05414734201667: JSN™
• 05414734201629: JSN™
• 05414734201612: JSN™
• 05414734201605: CRD-1™
• 05414734201575: CRD-1™
• 05414734201568: CRD-1™
• 05414734201551: CSL™
• 05414734201544: CSL™
• 05414734201537: CSL™
• 05414734201520: 401862
• 05414734201513: CRD-2™
• 05414734201506: CRD-2™
• 05414734201490: JSN-1
• 05414734201483: CRD-1™
• 05414734201476: CRD™
• 05414734201469: 401468
• 05414734201452: DAO-1™
• 05414734201445: DAO™
• 05414734201438: JSN™
• 05414734201421: JSN™
• 05414734201414: CRD™