Combo Kit PXAVMPL

GUDID 50690103200305

Pressure Monitoring Set

Edwards Lifesciences LLC

Invasive-pressure external transducer, single-use

• Primary Device ID: 50690103200305
• NIH Device Record Key: 95dd98ad-eb11-4402-b048-16143a56afde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Combo Kit
• Version Model Number: PXAVMPL
• Catalog Number: PXAVMPL
• 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	00690103200300 [Primary]
GS1	50690103200305 [Package]; Contains: 00690103200300; 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 [Combo Kit]

• 50690103200329: Pressure Monitoring Set
• 50690103200312: Pressure Monitoring Set
• 50690103200305: Pressure Monitoring Set