NON-DEHP, SINGLE DPT LINE WITH VAMP JR RESERVOIR AND LASS PXVJ050M

GUDID 07460691960572

PRESSURE MONITORING SET

Edwards Lifesciences LLC

Arterial blood sampling kit

• Primary Device ID: 07460691960572
• NIH Device Record Key: a8cd2a58-1aab-46a8-b080-2da6b7703d2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NON-DEHP, SINGLE DPT LINE WITH VAMP JR RESERVOIR AND LASS
• Version Model Number: PXVJ050M
• Catalog Number: PXVJ050M
• 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: true
• Serial Number: false
• 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(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• 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
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07460691960572 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142749

FDA Product Code

• DXO: Transducer, Pressure, Catheter Tip

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: 2025-07-23
• Device Publish Date: 2025-07-15

Devices Manufactured by Edwards Lifesciences LLC

• 00690103019261 - HEART VALVE SIZER ACCESSORY: 2026-02-18 CARPENTIER-EDWARDS AORTIC OBTURATOR
• 00690103186307 - REPLICA SIZER FOR MAGNA MITRAL EASE VALVE MODEL 7300TFX, NON-STERILE: 2026-02-18 CARPENTIER-EDWARDS PERIMOUNT MGNA MITRAL EASE REPLICA SIZER
• 00690103186314 - CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZER: 2026-02-18 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZE
• 00690103186321 - REPLICA SIZER FOR MAGNA MITRAL EASE VALVE MODEL 7300TFX, NON-STERILE: 2026-02-18 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZE
• 00690103186338 - CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZER: 2026-02-18 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZE
• 00690103186345 - CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZER: 2026-02-18 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZE
• 00690103186352 - CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZER: 2026-02-18 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZE
• 00690103186369 - BARREL SIZER FOR MAGNA MITRAL EASE VALVE MODEL 7300TFX, NON-STERILE: 2026-02-18 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE BARREL SIZER