TRUWAVE

Basic Information

• Brand Name: TRUWAVE
• Primary DI: 07460691951891
• Version / Model: 50P136
• Catalog Number: 50P136
• Company Name: Edwards Lifesciences LLC
• Labeler DUNS: 134139174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-03
• Public Version: 4
• Public Version Date: 2018-10-29
• Public Version Status: Update
• Public Device Record Key: cd920351-4fbd-4e8f-bd9c-0ba1e28e49aa

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
35927	Invasive-pressure external transducer, single-use	A sterile, noninvasive, non-luminal, electronic device designed to be connected to an appropriate invasive luminal device (e.g., catheter, cannula, tube, needle), to detect pressures (e.g., blood, gastrointestinal, urinary pressures) within the lumen and transmit them as electrical signals to an appropriate monitoring device. It consists of a pressure transducer and a connection cable and may be designed to be used with a pressure transducer dome. This is a single-use device.	No	Active
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
Primary	07460691951891	GS1
Package	57460691951896	GS1	Shipper	20	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K142749	000
K171996	000

Device Sizes

Type	Value	Unit	Text
Length	36	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: STORE IN A COOL, DRY PLACE.