SJM Regent™ 27AGFN-756

GUDID 05414734006385

ST. JUDE MEDICAL, INC.

Aortic bi-leaflet mechanical heart valve prosthesis

• Primary Device ID: 05414734006385
• NIH Device Record Key: ed1d5579-4ce8-4f67-93ea-99feba47334d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SJM Regent™
• Version Model Number: AGFN-756
• Catalog Number: 27AGFN-756
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• 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

Device Dimensions

• Outer Diameter: 27 Millimeter
• Outer Diameter: 27 Millimeter
• Outer Diameter: 27 Millimeter
• Outer Diameter: 27 Millimeter
• Outer Diameter: 27 Millimeter
• Outer Diameter: 27 Millimeter
• Outer Diameter: 27 Millimeter
• Outer Diameter: 27 Millimeter
• Outer Diameter: 27 Millimeter
• Outer Diameter: 27 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store SJM Regent Mechanical Heart Valve in cool, dry area until needed.
• Special Storage Condition, Specify: Between 0 and 0 *Store SJM Regent Mechanical Heart Valve in cool, dry area until needed.
• Special Storage Condition, Specify: Between 0 and 0 *Store SJM Regent Mechanical Heart Valve in cool, dry area until needed.
• Special Storage Condition, Specify: Between 0 and 0 *Store SJM Regent Mechanical Heart Valve in cool, dry area until needed.
• Special Storage Condition, Specify: Between 0 and 0 *Store SJM Regent Mechanical Heart Valve in cool, dry area until needed.
• Special Storage Condition, Specify: Between 0 and 0 *Store SJM Regent Mechanical Heart Valve in cool, dry area until needed.
• Special Storage Condition, Specify: Between 0 and 0 *Store SJM Regent Mechanical Heart Valve in cool, dry area until needed.
• Special Storage Condition, Specify: Between 0 and 0 *Store SJM Regent Mechanical Heart Valve in cool, dry area until needed.
• Special Storage Condition, Specify: Between 0 and 0 *Store SJM Regent Mechanical Heart Valve in cool, dry area until needed.
• Special Storage Condition, Specify: Between 0 and 0 *Store SJM Regent Mechanical Heart Valve in cool, dry area until needed.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734006385 [Primary]

FDA Product Code

• LWQ: HEART-VALVE, MECHANICAL

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: 2014-09-23

On-Brand Devices [SJM Regent™ ]

• 05414734009256: Mechanical Heart Valve
• 05414734006392: AGN-751
• 05414734006385: AGFN-756
• 05414734006279: AGN-751
• 05414734006262: AGFN-756
• 05414734006101: AGN-751
• 05414734006095: AGFN-756
• 05414734005982: AGN-751
• 05414734005975: AGFN-756
• 05414734005869: AGN-751
• 05414734005852: AGFN-756