TRUWAVE, VAMP PLUS PXVP0778

GUDID 00690103160468

PRESSURE MONITORING SET

Edwards Lifesciences LLC

Invasive-pressure external transducer, single-use

• Primary Device ID: 00690103160468
• NIH Device Record Key: 7cb51520-3921-4af4-9ee7-673a62f8310d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUWAVE, VAMP PLUS
• Version Model Number: PXVP0778
• Catalog Number: PXVP0778
• 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	00690103160468 [Primary]
GS1	50690103160463 [Package]; Package: Shipper [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142749

FDA Product Code

• KRA: Catheter, continuous flush

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: 2018-12-04
• Device Publish Date: 2016-09-03

On-Brand Devices [TRUWAVE, VAMP PLUS]

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• 07460691958425: PRESSURE MONITORING KIT - STERILE
• 07460691957923: PRESSURE MONITORING SET
• 07460691957886: PRESSURE MONITORING SET
• 07460691957350: PRESSURE MONITORING SET
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• 07460691957206: PRESSURE MONITORING SET
• 07460691956254: PRESSURE MONITORING SET
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• 07460691956193: PRESSURE MONITORING SET
• 07460691956025: PRESSURE MONITORING SET
• 07460691955936: PRESSURE MONITORING SET
• 07460691955486: PRESSURE MONITORING KIT - STERILE
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• 07460691955462: PRESSURE MONITORING KIT - STERILE
• 07460691955301: PRESSURE MONITORING KIT - STERILE
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• 07460691955165: PRESSURE MONITORING SET
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• 07460691950467: PRESSURE MONITORING SET
• 07460691950443: PRESSURE MONITORING SET
• 07460691950436: PRESSURE MONITORING SET
• 07460691950184: PRESSURE MONITORING SET
• 07460691950177: PRESSURE MONITORING SET
• 07460691950108: PRESSURE MONITORING SET
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• 07460691949911: PRESSURE MONITORING SET
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• 50690103200343: Pressure Monitoring Set
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• 50690103200398: Pressure Monitoring Set
• 57460691959489: PRESSURE MONITORING SET
• 57460691959472: PRESSURE MONITORING SET
• 50690103197124: PRESSURE MONITORING SET