TRUWAVE, VAMP T001745A

GUDID 57460691947462

PRESSURE MONITORING SET

Edwards Lifesciences LLC

Invasive-pressure external transducer, single-use

• Primary Device ID: 57460691947462
• NIH Device Record Key: 9555db18-5e56-48a4-af24-30773a24626a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUWAVE, VAMP
• Version Model Number: T001745A
• Catalog Number: T001745A
• 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

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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07460691947467 [Primary]
GS1	57460691947462 [Package]; Contains: 07460691947467; Package: Case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183413

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: 2024-09-12
• Device Publish Date: 2024-09-04

On-Brand Devices [TRUWAVE, VAMP]

• 00690103162141: PRESSURE MONITORING SET
• 00690103161830: PRESSURE MONITORING SET
• 00690103016802: PRESSURE MONITORING SET
• 00690103016765: PRESSURE MONITORING SET
• 00690103016581: PRESSURE MONITORING KIT - STERILE
• 00690103011494: PRESSURE MONITORING SET
• 07460691959439: PRESSURE MONITORING SET
• 07460691958760: PRESSURE MONITORING KIT - STERILE
• 07460691958753: PRESSURE MONITORING KIT - STERILE
• 07460691958661: PRESSURE MONITORING KIT - STERILE
• 07460691958340: PRESSURE MONITORING KIT - STERILE
• 07460691957879: PRESSURE MONITORING KIT - STERILE
• 07460691957862: PRESSURE MONITORING SET
• 07460691957671: PRESSURE MONITORING KIT - STERILE
• 07460691957534: PRESSURE MONITORING KIT - STERILE
• 07460691957527: PRESSURE MONITORING KIT - STERILE
• 07460691956667: PRESSURE MONITORING SET
• 07460691956575: PRESSURE MONITORING KIT - STERILE
• 07460691956216: PRESSURE MONITORING KIT - STERILE
• 07460691956209: PRESSURE MONITORING KIT - STERILE
• 07460691955431: PRESSURE MONITORING SET
• 07460691955127: PRESSURE MONITORING SET
• 07460691955110: PRESSURE MONITORING SET
• 07460691955103: PRESSURE MONITORING SET
• 07460691955097: PRESSURE MONITORING SET
• 07460691955080: PRESSURE MONITORING SET
• 07460691955073: PRESSURE MONITORING SET
• 07460691955035: PRESSURE MONITORING KIT - STERILE
• 07460691955028: PRESSURE MONITORING KIT
• 07460691955004: PRESSURE MONITORING KIT - STERILE
• 07460691954991: PRESSURE MONITORING KIT - STERILE
• 07460691954960: PRESSURE MONITORING SET
• 07460691954953: PRESSURE MONITORING SET
• 07460691954946: PRESSURE MONITORING KIT - STERILE
• 07460691954878: PRESSURE MONITORING SET
• 07460691954854: PRESSURE MONITORING KIT - STERILE
• 07460691954816: PRESSURE MONITORING SET
• 07460691954809: PRESSURE MONITORING SET
• 07460691954748: PRESSURE MONITORING SET
• 07460691954731: PRESSURE MONITORING KIT - STERILE
• 07460691954656: PRESSURE MONITORING KIT - STERILE
• 07460691954649: PRESSURE MONITORING SET
• 07460691954632: PRESSURE MONITORING KIT - STERILE
• 07460691954618: PRESSURE MONITORING SET
• 07460691954601: PRESSURE MONITORING SET
• 07460691954571: PRESSURE MONITORING KIT - STERILE
• 07460691954564: PRESSURE MONITORING SET
• 07460691954557: PRESSURE MONITORING SET
• 07460691954540: PRESSURE MONITORING SET
• 07460691954533: PRESSURE MONITORING KIT - STERILE