EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS - AORTIC 2500P25MM

GUDID 00690103144154

Edwards Lifesciences LLC

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