TRUWAVE/VAMP T490009M

GUDID 50690103197131

PRESSURE MONITORING SET

Edwards Lifesciences LLC

Invasive-pressure external transducer, single-use

• Primary Device ID: 50690103197131
• NIH Device Record Key: b4e8ab86-35ad-4632-9bbe-f3e4406c03ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUWAVE/VAMP
• Version Model Number: T490009M
• Catalog Number: T490009M
• 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: false
• Manufacturing Date: false
• 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(800)822-9637
• Email: tech_support@edwards.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103197136 [Primary]
GS1	50690103197131 [Package]; Contains: 00690103197136; Package: Shipper [10 Units]; In Commercial Distribution

FDA Product Code

• DXO: Transducer, Pressure, Catheter Tip

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-01
• Device Publish Date: 2020-04-23

Devices Manufactured by Edwards Lifesciences LLC

• 00690103019353 - AORTIC TRUE-SIZE OBTURATOR 19MM: 2026-02-23 AORTIC TRUE-SIZE OBTURATOR F/USE W/1108 HDLE
• 00690103019360 - AORTIC TRUE-SIZE OBTURATOR 21MM: 2026-02-23 AORTIC TRUE-SIZE OBTURATOR F/USE W/1108 HDLE
• 00690103019377 - AORTIC TRUE-SIZE OBTURATOR 23MM: 2026-02-23 AORTIC TRUE-SIZE OBTURATOR F/USE W/1108 HDLE
• 00690103019384 - AORTIC TRUE-SIZE OBTURATOR 25MM: 2026-02-23 AORTIC TRUE-SIZE OBTURATOR F/USE W/1108 HDLE
• 00690103019391 - AORTIC TRUE-SIZE OBTURATOR 27MM: 2026-02-23 AORTIC TRUE-SIZE OBTURATOR F/USE W/1108 HDLE
• 00690103019407 - AORTIC TRUE-SIZE OBTURATOR 29MM: 2026-02-23 AORTIC TRUE-SIZE OBTURATOR F/USE W/1108 HDLE
• 00690103019414 - AORTIC TRUE-SIZE OBTURATOR 31MM: 2026-02-23 AORTIC TRUE-SIZE OBTURATOR F/USE W/1108 HDLE
• 00690103019278 - HEART VALVE SIZER ACCESSORY: 2026-02-19 CARPENTIER-EDWARDS AORTIC OBTURATOR