TruWave, VAMP Plus PXVPL2284

GUDID 50690103200343

Pressure Monitoring Set

Edwards Lifesciences LLC

Invasive-pressure external transducer, single-use

• Primary Device ID: 50690103200343
• NIH Device Record Key: cfe9db3e-094d-43b1-b8e3-292e5a87811d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruWave, VAMP Plus
• Version Model Number: PXVPL2284
• Catalog Number: PXVPL2284
• 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	00690103200348 [Primary]
GS1	50690103200343 [Package]; Contains: 00690103200348; Package: Shipper [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141495

FDA Product Code

• DXO: Transducer, Pressure, Catheter Tip

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-25
• Device Publish Date: 2019-04-17

On-Brand Devices [TruWave, VAMP Plus]

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• 00690103197969: PRESSURE MONITORING SET
• 00690103160468: PRESSURE MONITORING SET
• 07460691959149: PRESSURE MONITORING SET
• 07460691958449: PRESSURE MONITORING KIT - STERILE
• 07460691958425: PRESSURE MONITORING KIT - STERILE
• 07460691957923: PRESSURE MONITORING SET
• 07460691957886: PRESSURE MONITORING SET
• 07460691957350: PRESSURE MONITORING SET
• 07460691957213: PRESSURE MONITORING KIT - STERILE
• 07460691957206: PRESSURE MONITORING SET
• 07460691956254: PRESSURE MONITORING SET
• 07460691956247: PRESSURE MONITORING SET
• 07460691956193: PRESSURE MONITORING SET
• 07460691956025: PRESSURE MONITORING SET
• 07460691955936: PRESSURE MONITORING SET
• 07460691955486: PRESSURE MONITORING KIT - STERILE
• 07460691955479: PRESSURE MONITORING KIT - STERILE
• 07460691955462: PRESSURE MONITORING KIT - STERILE
• 07460691955301: PRESSURE MONITORING KIT - STERILE
• 07460691955172: PRESSURE MONITORING KIT - STERILE
• 07460691955165: PRESSURE MONITORING SET
• 07460691950498: PRESSURE MONITORING SET
• 07460691950467: PRESSURE MONITORING SET
• 07460691950443: PRESSURE MONITORING SET
• 07460691950436: PRESSURE MONITORING SET
• 07460691950184: PRESSURE MONITORING SET
• 07460691950177: PRESSURE MONITORING SET
• 07460691950108: PRESSURE MONITORING SET
• 07460691950092: PRESSURE MONITORING SET
• 07460691949911: PRESSURE MONITORING SET
• 07460691949348: PRESSURE MONITORING SET
• 50690103200343: Pressure Monitoring Set
• 50690103200008: Pressure Monitoring Set
• 50690103200404: Pressure Monitoring Set
• 50690103200381: Pressure Monitoring Set
• 50690103200398: Pressure Monitoring Set
• 57460691959489: PRESSURE MONITORING SET
• 57460691959472: PRESSURE MONITORING SET
• 50690103197124: PRESSURE MONITORING SET