Agilis™ NxT G408325

GUDID 05414734216630

ST. JUDE MEDICAL, INC.

Cardiovascular device introducer, steerable

• Primary Device ID: 05414734216630
• NIH Device Record Key: 1fc9bfdc-b7fb-4dc4-8073-bb24083d8e0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Agilis™ NxT
• Version Model Number: G408325
• Catalog Number: G408325
• 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: 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
• 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: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734216630 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083083

FDA Product Code

• DYB: INTRODUCER, CATHETER

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-03-06

On-Brand Devices [Agilis™ NxT]

• 05414734217972: G408332
• 05414734216630: G408325
• 05414734206150: G408324
• 05414734206143: G408321
• 05414734206136: G408320
• 05414734206129: G408319
• 05414734206112: G408318
• 05414734206105: 408310
• 05414734206099: 408309