Trifecta™ TF2000-19

GUDID 05415067005410

ST. JUDE MEDICAL, INC.

Heart valve sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable

• Primary Device ID: 05415067005410
• NIH Device Record Key: 1a73c78f-406d-4b61-8ea0-9bcc3e51c1bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trifecta™
• Version Model Number: 19 mm Sizer
• Catalog Number: TF2000-19
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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

Device Dimensions

• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067005410 [Primary]

FDA Product Code

• DTI: SIZER, HEART-VALVE, PROSTHESIS

Sterilization

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

[05415067005410]

Moist Heat or Steam Sterilization

[05415067005410]

Moist Heat or Steam Sterilization

[05415067005410]

Moist Heat or Steam Sterilization

[05415067005410]

Moist Heat or Steam Sterilization

[05415067005410]

Moist Heat or Steam Sterilization

[05415067005410]

Moist Heat or Steam Sterilization

[05415067005410]

Moist Heat or Steam Sterilization

[05415067005410]

Moist Heat or Steam Sterilization

[05415067005410]

Moist Heat or Steam Sterilization

[05415067005410]

Moist Heat or Steam Sterilization

[05415067005410]

Moist Heat or Steam Sterilization

[05415067005410]

Moist Heat or Steam Sterilization

[05415067005410]

Moist Heat or Steam Sterilization

[05415067005410]

Moist Heat or Steam Sterilization

[05415067005410]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-11-13

On-Brand Devices [Trifecta™]

• 05415067027566: Valve Series TF2000-VR Sizer Set
• 05415067025951: Valve Sizer Set
• 05415067018274: Valve Flexible Holder Handle
• 05415067018267: Valve Rigid Holder Handle
• 05415067018250: Aortic Pericardial Bioprosthetic Heart Valve with Glide™ Technology
• 05415067018243: Aortic Pericardial Bioprosthetic Heart Valve with Glide™ Technology
• 05415067018236: Aortic Pericardial Bioprosthetic Heart Valve with Glide™ Technology
• 05415067018229: Aortic Pericardial Bioprosthetic Heart Valve with Glide™ Technology
• 05415067018212: Aortic Pericardial Bioprosthetic Heart Valve with Glide™ Technology
• 05415067018205: Aortic Pericardial Bioprosthetic Heart Valve with Glide™ Technology
• 05415067005465: 29mm Sizer
• 05415067005458: 27 mm Sizer
• 05415067005441: 25 mm Sizer
• 05415067005434: 23 mm Sizer
• 05415067005427: 21 mm Sizer
• 05415067005410: 19 mm Sizer
• 05414734052078: Valve TF2000 Sizer Set
• 05414734052061: TF-A
• 05414734052054: TF-A
• 05414734052047: TF-A
• 05414734052030: TF-A
• 05414734052023: TF-A
• 05414734052016: TF-A