SJM™ Mechanical Heart Valve 21M-101

GUDID 05414734006033

Mitral Mechanical Heart Valve

ST. JUDE MEDICAL, INC.

Mitral bi-leaflet mechanical heart valve prosthesis

• Primary Device ID: 05414734006033
• NIH Device Record Key: ad1994dc-c447-4058-a2ff-9fd506237dbb
• Commercial Distribution Discontinuation: 2018-01-12
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SJM™ Mechanical Heart Valve
• Version Model Number: M-101
• Catalog Number: 21M-101
• 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: 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	05414734006033 [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™ Mechanical Heart Valve]

• 05414734006651: Mitral Mechanical Heart Valve
• 05414734006590: Mitral Mechanical Heart Valve
• 05414734006569: Aortic Mechanical Heart Valve
• 05414734006521: Mitral Mechanical Heart Valve
• 05414734006477: Aortic Mechanical Heart Valve
• 05414734006439: Mechanical Heart Valve Mitral
• 05414734006361: Aortic Mechanical Heart Valve
• 05414734006323: Mitral Mechanical Heart Valve
• 05414734006248: Aortic Mechanical Heart Valve
• 05414734006156: M-101
• 05414734006071: A-101
• 05414734006033: Mitral Mechanical Heart Valve
• 05414734005951: A-101
• 05414734005913: M-101
• 05414734005838: A-101