EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS - AORTIC 2500P25MM

GUDID 00690103144154

Edwards Lifesciences LLC

Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis

• Primary Device ID: 00690103144154
• NIH Device Record Key: 21d0aebc-97bd-4e96-81a4-e116880974e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS - AORTIC
• Version Model Number: 2500P
• Catalog Number: 2500P25MM
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800.822.9837
• Email: tech_support@edwards.com
• Phone: 800.822.9837
• Email: tech_support@edwards.com
• Phone: 800.822.9837
• Email: tech_support@edwards.com
• Phone: 800.822.9837
• Email: tech_support@edwards.com
• Phone: 800.822.9837
• Email: tech_support@edwards.com
• Phone: 800.822.9837
• Email: tech_support@edwards.com
• Phone: 800.822.9837
• Email: tech_support@edwards.com
• Phone: 800.822.9837
• Email: tech_support@edwards.com
• Phone: 800.822.9837
• Email: tech_support@edwards.com
• Phone: 800.822.9837
• Email: tech_support@edwards.com
• Phone: 800.822.9837
• Email: tech_support@edwards.com
• Phone: 800.822.9837
• Email: tech_support@edwards.com
• Phone: 800.822.9837
• Email: tech_support@edwards.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103144154 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P000007

FDA Product Code

• DYE: replacement Heart-valve

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-08-30

On-Brand Devices [EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS - AORTIC]

• 00690103144161: 2500P
• 00690103144154: 2500P
• 00690103144147: 2500P
• 00690103144130: 2500P
• 00690103144123: 2500P
• 00690103144116: 2500P