TRUWAVE, VAMP JR. PXVJ0096

GUDID 50690103199401

TRUWAVE (3CC) /VAMP JR. 60 IN (153 CM)

Edwards Lifesciences LLC

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• Primary Device ID: 50690103199401
• NIH Device Record Key: 843c14ad-9957-437b-a44e-05e5527191b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUWAVE, VAMP JR.
• Version Model Number: PXVJ0096
• Catalog Number: PXVJ0096
• 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
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• 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
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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	00690103199406 [Primary]
GS1	50690103199401 [Package]; Contains: 00690103199406; Package: SHIPPER [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171996

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: 2020-09-03
• Device Publish Date: 2020-08-26

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)