Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-S

GUDID 05415067050182

Steerable Introducer

ST. JUDE MEDICAL, INC.

Vascular guide-catheter, single-use

• Primary Device ID: 05415067050182
• NIH Device Record Key: e11777b4-538b-4c8d-b451-d2249ecf1dac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Agilis™ NxT Steerable Introducer Dual-Reach™
• Version Model Number: SI-1371-S
• Catalog Number: SI-1371-S
• 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
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Device Dimensions

• Catheter Gauge: 13 French
• Length: 71 Centimeter
• Catheter Gauge: 13 French
• Length: 71 Centimeter
• Catheter Gauge: 13 French
• Length: 71 Centimeter
• Catheter Gauge: 13 French
• Length: 71 Centimeter
• Catheter Gauge: 13 French
• Length: 71 Centimeter
• Catheter Gauge: 13 French
• Length: 71 Centimeter
• Catheter Gauge: 13 French
• Length: 71 Centimeter
• Catheter Gauge: 13 French
• Length: 71 Centimeter
• Catheter Gauge: 13 French
• Length: 71 Centimeter
• Catheter Gauge: 13 French
• Length: 71 Centimeter
• Catheter Gauge: 13 French
• Length: 71 Centimeter
• Catheter Gauge: 13 French
• Length: 71 Centimeter
• Catheter Gauge: 13 French
• Length: 71 Centimeter
• Catheter Gauge: 13 French
• Length: 71 Centimeter
• Catheter Gauge: 13 French
• Length: 71 Centimeter
• Catheter Gauge: 13 French
• Length: 71 Centimeter
• Catheter Gauge: 13 French
• Length: 71 Centimeter

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at 10-25°C. Excursions permitted from -20-50°C. Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at 10-25°C. Excursions permitted from -20-50°C. Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at 10-25°C. Excursions permitted from -20-50°C. Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at 10-25°C. Excursions permitted from -20-50°C. Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at 10-25°C. Excursions permitted from -20-50°C. Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at 10-25°C. Excursions permitted from -20-50°C. Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at 10-25°C. Excursions permitted from -20-50°C. Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at 10-25°C. Excursions permitted from -20-50°C. Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at 10-25°C. Excursions permitted from -20-50°C. Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at 10-25°C. Excursions permitted from -20-50°C. Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at 10-25°C. Excursions permitted from -20-50°C. Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at 10-25°C. Excursions permitted from -20-50°C. Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at 10-25°C. Excursions permitted from -20-50°C. Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at 10-25°C. Excursions permitted from -20-50°C. Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at 10-25°C. Excursions permitted from -20-50°C. Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at 10-25°C. Excursions permitted from -20-50°C. Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at 10-25°C. Excursions permitted from -20-50°C. Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067050182 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241370

FDA Product Code

• DYB: Introducer, catheter

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: 2024-08-23
• Device Publish Date: 2024-08-15

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