VitaWave

Basic Information

• Brand Name: VitaWave
• Primary DI: 00690103219609
• Version / Model: VWCA2
• Catalog Number: VWCA2
• Company Name: Edwards Lifesciences LLC
• Labeler DUNS: 134139174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-10
• Public Version: 1
• Public Version Date: 2025-09-18
• Public Version Status: New
• Public Device Record Key: d86ddfa6-0b9a-432a-9a11-5a3d466aef81

Device Description

VitaWave Plus Finger Cuff

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: MR Unsafe
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQK	Computer, Diagnostic, Programmable	Cardiovascular	870.1425	2
DQE	Catheter, Oximeter, Fiber-Optic	Cardiovascular	870.1230	2
QAQ	Adjunctive Predictive Cardiovascular Indicator	Cardiovascular	870.2210	2
MUD	Oximeter, Tissue Saturation	Cardiovascular	870.2700	2
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	870.1130	2
DSB	Plethysmograph, Impedance	Cardiovascular	870.2770	2
FLL	Continuous Measurement Thermometer	General Hospital	880.2910	2
QMS	Adjunctive Open Loop Fluid Therapy Recommender	Cardiovascular	870.5600	2
OLW	Index-Generating Electroencephalograph Software	Neurology	882.1400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37326	Blood pressure cuff, single-use	A band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is typically wrapped around the upper arm of the patient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50690103219604	GS1	CASE	5	In Commercial Distribution
Primary	00690103219609	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K243781	000