EV1000

Basic Information

• Brand Name: EV1000
• Primary DI: 00690103193497
• Version / Model: EVHRSBP
• Catalog Number: EVHRSBP
• Company Name: Edwards Lifesciences LLC
• Labeler DUNS: 134139174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-09-03
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 81fe895f-4a9c-4edd-8ef2-3383930b4536

Device Description

HEART REFERENCE SENSOR BODY PADS

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: No
• 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
DSB	PLETHYSMOGRAPH, IMPEDANCE	Cardiovascular	870.2770	2
DXN	SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE	Cardiovascular	870.1130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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	00690103193497	GS1
Unit of Use	70690103193496	GS1
Package	50690103193492	GS1	Shipper	4	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K140312	000
K160552	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			SIZED FOR USE WITH THE EDWARDS EV1000 HEART REFERENCE SENSOR (MODEL EVHRS)

Storage Conditions

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