TRUWAVE, VAMP PXVK0398

GUDID 07460691954564

PRESSURE MONITORING SET

Edwards Lifesciences LLC

Invasive-pressure external transducer, single-use

• Primary Device ID: 07460691954564
• NIH Device Record Key: 9fd5523f-744a-4618-87ed-ad9a260b7b6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUWAVE, VAMP
• Version Model Number: PXVK0398
• Catalog Number: PXVK0398
• 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

• Total Volume: 3 Milliliter

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	07460691954564 [Primary]
GS1	57460691954569 [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: 5
• Public Version Date: 2018-11-28
• Device Publish Date: 2016-09-03

On-Brand Devices [TRUWAVE, VAMP]

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• 00690103016802: PRESSURE MONITORING SET
• 00690103016765: PRESSURE MONITORING SET
• 00690103016581: PRESSURE MONITORING KIT - STERILE
• 00690103011494: PRESSURE MONITORING SET
• 07460691959439: PRESSURE MONITORING SET
• 07460691958760: PRESSURE MONITORING KIT - STERILE
• 07460691958753: PRESSURE MONITORING KIT - STERILE
• 07460691958661: PRESSURE MONITORING KIT - STERILE
• 07460691958340: PRESSURE MONITORING KIT - STERILE
• 07460691957879: PRESSURE MONITORING KIT - STERILE
• 07460691957862: PRESSURE MONITORING SET
• 07460691957671: PRESSURE MONITORING KIT - STERILE
• 07460691957534: PRESSURE MONITORING KIT - STERILE
• 07460691957527: PRESSURE MONITORING KIT - STERILE
• 07460691956667: PRESSURE MONITORING SET
• 07460691956575: PRESSURE MONITORING KIT - STERILE
• 07460691956216: PRESSURE MONITORING KIT - STERILE
• 07460691956209: PRESSURE MONITORING KIT - STERILE
• 07460691955431: PRESSURE MONITORING SET
• 07460691955127: PRESSURE MONITORING SET
• 07460691955110: PRESSURE MONITORING SET
• 07460691955103: PRESSURE MONITORING SET
• 07460691955097: PRESSURE MONITORING SET
• 07460691955080: PRESSURE MONITORING SET
• 07460691955073: PRESSURE MONITORING SET
• 07460691955035: PRESSURE MONITORING KIT - STERILE
• 07460691955028: PRESSURE MONITORING KIT
• 07460691955004: PRESSURE MONITORING KIT - STERILE
• 07460691954991: PRESSURE MONITORING KIT - STERILE
• 07460691954960: PRESSURE MONITORING SET
• 07460691954953: PRESSURE MONITORING SET
• 07460691954946: PRESSURE MONITORING KIT - STERILE
• 07460691954878: PRESSURE MONITORING SET
• 07460691954854: PRESSURE MONITORING KIT - STERILE
• 07460691954816: PRESSURE MONITORING SET
• 07460691954809: PRESSURE MONITORING SET
• 07460691954748: PRESSURE MONITORING SET
• 07460691954731: PRESSURE MONITORING KIT - STERILE
• 07460691954656: PRESSURE MONITORING KIT - STERILE
• 07460691954649: PRESSURE MONITORING SET
• 07460691954632: PRESSURE MONITORING KIT - STERILE
• 07460691954618: PRESSURE MONITORING SET
• 07460691954601: PRESSURE MONITORING SET
• 07460691954571: PRESSURE MONITORING KIT - STERILE
• 07460691954564: PRESSURE MONITORING SET
• 07460691954557: PRESSURE MONITORING SET
• 07460691954540: PRESSURE MONITORING SET
• 07460691954533: PRESSURE MONITORING KIT - STERILE