EV1000

Basic Information

• Brand Name: EV1000
• Primary DI: 00690103190106
• Version / Model: EV1000M
• Catalog Number: EV1000M
• 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: 7
• Public Version Date: 2021-11-10
• Public Version Status: Update
• Public Device Record Key: e14ef4df-f913-4751-b351-5a7fb90d3456

Device Description

EV1000 MONITOR

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DSB	PLETHYSMOGRAPH, IMPEDANCE	Cardiovascular	870.2770	2
DXN	SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE	Cardiovascular	870.1130	2
DXG	COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION	Cardiovascular	870.1435	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36551	Patient monitoring system module, blood pressure, noninvasive	A small unit dedicated to the measurement of noninvasive blood pressure (indirect method) obtained through a standard sphygmomanometer cuff placed on the arm or leg. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the blood pressure parameter/information measured and provided by this module.	No	Active
33586	General-purpose multi-parameter bedside monitor	An electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and is not intended to be worn on the body.	No	Active
43267	Patient positioning sensor	A device designed to detect and respond to movement and transmits a signal proportional to the degree of motion. A parent device will receive these signals and show the position of the sensor and the object to which it is attached and make the necessary display/control adjustments for the object being monitored. It may be permanently attached to an electrical cable that relays energy to the sensor and signals back to the parent device. It may be affixed to the leg of a patient during computer assisted surgery (CAS) for implantation of a hip prosthesis to assist in the correct positioning of the implant or as a component of an electromagnetic device tracking system. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00690103190106	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K131892	000
K140312	000
K160552	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			HEIGHT: 226 MM, WIDTH: 296 MM, DEPTH: 58.6 MM, WEIGHT: 2.1 KG (4.6 LBS)

Storage Conditions

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