Trifecta™ TF2000-21

GUDID 05415067005427

ST. JUDE MEDICAL, INC.

Heart valve sizer, reusable

• Primary Device ID: 05415067005427
• NIH Device Record Key: aa8a3d08-d520-4bf9-b011-887ed1b7cd16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trifecta™
• Version Model Number: 21 mm Sizer
• Catalog Number: TF2000-21
• 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: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067005427 [Primary]

FDA Product Code

• DTI: SIZER, HEART-VALVE, PROSTHESIS

Sterilization

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

[05415067005427]

Moist Heat or Steam Sterilization

[05415067005427]

Moist Heat or Steam Sterilization

[05415067005427]

Moist Heat or Steam Sterilization

[05415067005427]

Moist Heat or Steam Sterilization

[05415067005427]

Moist Heat or Steam Sterilization

[05415067005427]

Moist Heat or Steam Sterilization

[05415067005427]

Moist Heat or Steam Sterilization

[05415067005427]

Moist Heat or Steam Sterilization

[05415067005427]

Moist Heat or Steam Sterilization

[05415067005427]

Moist Heat or Steam Sterilization

[05415067005427]

Moist Heat or Steam Sterilization

[05415067005427]

Moist Heat or Steam Sterilization

[05415067005427]

Moist Heat or Steam Sterilization

[05415067005427]

Moist Heat or Steam Sterilization

[05415067005427]

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