PRESSURE TUBING T530122D

GUDID 57460691949633

PRESSURE MONITORING ACCESSORY

Edwards Lifesciences LLC

Invasive blood pressure monitoring tubing set

• Primary Device ID: 57460691949633
• NIH Device Record Key: 8c7f004f-8378-476e-a7ee-366751ed53e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRESSURE TUBING
• Version Model Number: T530122D
• Catalog Number: T530122D
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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

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	07460691949638 [Primary]
GS1	57460691949633 [Package]; Contains: 07460691949638; Package: Shipper [20 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: 2018-11-09
• Device Publish Date: 2018-10-09

On-Brand Devices [PRESSURE TUBING]

• 57460691949633: PRESSURE MONITORING ACCESSORY
• 57460691944478: PRESSURE MONITORING ACCESSORY
• 57460691910152: PRESSURE MONITORING ACCESSORY