TRUWAVE, VAMP JR. PXVJ0441

GUDID 07460691954458

PRESSURE MONITORING SET

Edwards Lifesciences LLC

Invasive-pressure external transducer, single-use

• Primary Device ID: 07460691954458
• NIH Device Record Key: 9982f9c8-5177-42d7-b411-a1367cf973a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUWAVE, VAMP JR.
• Version Model Number: PXVJ0441
• Catalog Number: PXVJ0441
• 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	07460691954458 [Primary]
GS1	57460691954453 [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: 2016-09-03

On-Brand Devices [TRUWAVE, VAMP JR.]

• 07460691958869: PRESSURE MONITORING SET
• 07460691958746: PRESSURE MONITORING SET
• 07460691954502: PRESSURE MONITORING SET
• 07460691954489: PRESSURE MONITORING SET
• 07460691954472: PRESSURE MONITORING KIT - STERILE
• 07460691954465: PRESSURE MONITORING SET
• 07460691954458: PRESSURE MONITORING SET
• 07460691950542: PRESSURE MONITORING SET.
• 07460691950375: PRESSURE MONITORING SET
• 50690103200282: Pressure Monitoring Set
• 50690103199401: TRUWAVE (3CC) /VAMP JR. 60 IN (153 CM)