TRUWAVE(3 CC)/ VAMP PLUS 86 IN (218 CM) PXVPL0029

GUDID 50690103197681

PRESSURE MONITORING SET

Edwards Lifesciences LLC

Arterial blood sampling kit

• Primary Device ID: 50690103197681
• NIH Device Record Key: c8277b29-28c2-4efd-bffb-5373c4b95d68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUWAVE(3 CC)/ VAMP PLUS 86 IN (218 CM)
• Version Model Number: PXVPL0029
• Catalog Number: PXVPL0029
• 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	00690103197686 [Primary]
GS1	50690103197681 [Package]; Contains: 00690103197686; 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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-08-08
• Device Publish Date: 2019-05-30

Devices Manufactured by Edwards Lifesciences LLC

• 00690103019063 - HEART VALVE HANDLE ACCESSORY: 2024-10-28 HDLE,MITRAL ST/STEEL F/USE W/ 6625 OR 9120R HEART VLV
• 50690103019242 - DISPOSABLE HANDLE FOR VALVES/SIZERS: 2024-10-28 DISPOSABLE HANDLE FOR VALVES/SIZERS
• 00690103019339 - HEART VALVE ACCESSOR: 2024-10-28 HANDLE,F/USE W/C-E PHYSIO RING MODEL 4450 N/S
• 00690103166989 - HEART VALVE ACCESSOR: 2024-10-28 MITRAL SIZER HANDLE
• 00690103177701 - A HANDLE COMPATIBLE WITH RING HOLDERS MODELS 5100, 4900, 4100, 4200, 4450 AND 46: 2024-10-28 RING HANDLE - EXTENDED 4"
• 00690103186437 - FLEXIBLE HANDLE: 2024-10-28 FLEXIBLE HANDLE
• 00690103210132 - MITRIS Handle 1140M: 2024-10-28 11400M valve handle
• 00690103217773 - Edwards EVOQUE Loading System: 2024-10-11 Edwards EVOQUE Loading System