TRUWAVE,VAMP PLUS PXVP0041

GUDID 00690103197983

PRESSURE MONITORING SET

Edwards Lifesciences LLC

Arterial blood sampling kit

• Primary Device ID: 00690103197983
• NIH Device Record Key: 9c5fc4b2-6a5a-4778-bd0c-2e30a6d32514
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUWAVE,VAMP PLUS
• Version Model Number: PXVP0041
• Catalog Number: PXVP0041
• 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
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103197983 [Primary]
GS1	50690103197988 [Package]; Package: Shipper [10 Units]; In Commercial Distribution

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-20

On-Brand Devices [TRUWAVE,VAMP PLUS]

• 00690103197983: PRESSURE MONITORING SET
• 00690103197976: PRESSURE MONITORING SET