CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESIS 2800TFX25MM

GUDID 00690103194104

CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESIS

Edwards Lifesciences LLC

Aortic heart valve bioprosthesis

• Primary Device ID: 00690103194104
• NIH Device Record Key: 49573f39-b708-4982-8eda-c80806892f1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESIS
• Version Model Number: 2800TFX
• Catalog Number: 2800TFX25MM
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• 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: false
• 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

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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103194104 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P860057

FDA Product Code

• DYE: Replacement Heart-Valve

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-05
• Device Publish Date: 2019-11-27

On-Brand Devices [CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESIS]

• 00690103194104: CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESIS
• 00690103194098: CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESIS
• 00690103194128: CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESIS