TRUWAVE

Basic Information

• Brand Name: TRUWAVE
• Primary DI: 07460691944572
• Version / Model: VLMFV150
• Catalog Number: VLMFV150
• Company Name: Edwards Lifesciences LLC
• Labeler DUNS: 134139174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-15
• Public Version: 1
• Public Version Date: 2018-09-17
• Public Version Status: New
• Public Device Record Key: d7840794-5f8a-4c7f-9874-499067eee7a9

Device Description

PRESSURE TUBING

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXO	Transducer, Pressure, Catheter Tip	Cardiovascular	870.2870	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35529	Invasive blood pressure monitoring tubing set	A collection of devices that includes the necessary tubing and other items, e.g., connectors, stopcock(s), clamps and filters, used as an external connection for invasive blood pressure measurement. This set will interface, either directly or from an intermediate stopcock, between the applied invasive catheter and the measuring transducer. It will have physical characteristics appropriate for preserving, to the extent possible, the waveform and fidelity of the measured pressure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	27460691944576	GS1	Shipper	10	In Commercial Distribution
Primary	07460691944572	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K171996	000

Device Sizes

Type	Value	Unit	Text
Length	60	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dry place.