405522

GUDID 05415067004802

Vessel Dilator

ST. JUDE MEDICAL, INC.

Vascular dilator, single-use

• Primary Device ID: 05415067004802
• NIH Device Record Key: 1e4c2635-3b5b-4c93-9f0c-dbc2853bc9aa
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 405522
• Catalog Number: 405522
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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
• 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

• Length: 19 Centimeter
• Catheter Gauge: 4 French
• Length: 19 Centimeter
• Catheter Gauge: 4 French
• Length: 19 Centimeter
• Catheter Gauge: 4 French
• Length: 19 Centimeter
• Catheter Gauge: 4 French
• Length: 19 Centimeter
• Catheter Gauge: 4 French
• Length: 19 Centimeter
• Catheter Gauge: 4 French
• Length: 19 Centimeter
• Catheter Gauge: 4 French
• Length: 19 Centimeter
• Catheter Gauge: 4 French
• Length: 19 Centimeter
• Catheter Gauge: 4 French
• Length: 19 Centimeter
• Catheter Gauge: 4 French
• Length: 19 Centimeter
• Catheter Gauge: 4 French
• Length: 19 Centimeter
• Catheter Gauge: 4 French
• Length: 19 Centimeter
• Catheter Gauge: 4 French
• Length: 19 Centimeter
• Catheter Gauge: 4 French
• Length: 19 Centimeter
• Catheter Gauge: 4 French
• Length: 19 Centimeter
• Catheter Gauge: 4 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067004802 [Previous]
GS1	05415067042699 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K894330

FDA Product Code

• DRE: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-24
• Device Publish Date: 2022-02-16

Devices Manufactured by ST. JUDE MEDICAL, INC.

• 05414734504706 - Merlin@home™: 2024-11-12 Wireless Broadband Kit
• 05415067000989 - NA: 2024-10-09 AUX Out Cable
• 05415067006028 - NA: 2024-10-09 Adapter Cable
• 05415067049667 - EnSite™: 2024-09-09 X EP System Catheter Connector Cable
• 05415067049889 - Advisor™ HD Grid X, Sensor Enabled™: 2024-09-02 High Density Mapping Catheter
• 05415067050182 - Agilis™ NxT Steerable Introducer Dual-Reach™: 2024-08-23 Steerable Introducer
• 05415067049704 - EnSite™: 2024-08-22 X EP System Software Upgrade
• 05415067049711 - EnSite™: 2024-08-22 X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade