TRUWAVE/ VAMP PLUS PXVPL0030

GUDID 50690103197698

PRESSURE MONITORING SET

Edwards Lifesciences LLC

Arterial blood sampling kit

• Primary Device ID: 50690103197698
• NIH Device Record Key: 4c8eebfd-f7d6-4bf2-a589-88db91741b54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUWAVE/ VAMP PLUS
• Version Model Number: PXVPL0030
• Catalog Number: PXVPL0030
• 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: true
• 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

Device Dimensions

• Device Size Text, specify: 0

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	00690103197693 [Primary]
GS1	50690103197698 [Package]; Contains: 00690103197693; Package: Shipper [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141495

FDA Product Code

• KRA: Catheter, Continuous Flush

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: 2019-07-11
• Device Publish Date: 2019-07-03

Devices Manufactured by Edwards Lifesciences LLC

• 00690103219494 - Edwards Reusable Rail Extension: 2025-07-17 Edwards Reusable Rail Extension
• 00690103219500 - Edwards Reusable Rail: 2025-07-17 Edwards Reusable Rail
• 00690103219562 - Edwards EVOQUE Loading System: 2025-07-17 Edwards EVOQUE Loading System
• 00690103219579 - Edwards EVOQUE Stabilizer: 2025-07-17 Edwards EVOQUE Stabilizer
• 00690103220001 - Edwards rail tray: 2025-07-17 Edwards rail tray
• 00690103220629 - ESHEATH OPTIMA INTRODUCER SET (14F): 2025-05-15 eSheath Optima Introducer Set (14F)
• 00690103217957 - HemoSphere Alta: 2025-03-21 HemoSphere Alta advanced monitor (All-on-one)
• 00690103217964 - HemoSphere Alta: 2025-03-21 HemoSphere Alta advanced monitor (Smart Recovery)