EV1000

Basic Information

• Brand Name: EV1000
• Primary DI: 00690103193480
• Version / Model: PC2B
• Catalog Number: PC2B
• 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: 2023-05-03
• Public Version Status: Update
• Public Device Record Key: 3a37ea71-0fad-465b-8e70-3674f08d4d4f

Device Description

PRESSURE CONTROLLER BAND

Device Characteristics

• Single Use: No
• 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: 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

GMDN Terms

Code	Name	Definition	Implantable	Status
42410	Electrical cable/lead holder	A device intended to hold medical cables/leads, primarily those that convey electricity and electrical signals. It is typically used in conjunction with an electrocardiograph (ECG) or an electromyograph (EMG) to support and stabilize electrical cable/leads used during patient treatment. It is typically designed as a jointed, adjustable arm with a mounting fixture, that attaches to the recording device, and a holder at the distal end to hold the cables/leads near the patient; it is intended to help organize and protect the cables/leads to prolong their life and help prevent patient disconnection. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00690103193480	GS1
Package	50690103193485	GS1	Shipper	5	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 NI PRESSURE CONTROLLER (MODEL PC)

Storage Conditions

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