Arc Essentia

Basic Information

• Brand Name: Arc Essentia
• Primary DI: 00840067100080
• Version / Model: 190294-200
• Company Name: CADWELL INDUSTRIES, INC.
• Labeler DUNS: 098554157
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-05
• Public Version: 5
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: d30c8c89-eff2-43a5-8453-fcf58b05c015

Device Description

Essentia Remote Input Box

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• 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
GWL	AMPLIFIER, PHYSIOLOGICAL SIGNAL	Neurology	882.1835	2
OLT	Non-normalizing quantitative electroencephalograph software	Neurology	882.1400	2
OMC	Reduced- montage standard electroencephalograph	Neurology	882.1400	2
OLV	Standard polysomnograph with electroencephalograph	Neurology	882.1400	2
GWQ	Full-montage Standard Electroencephalograph	Neurology	882.1400	2
GWE	Stimulator, photic, evoked response	Neurology	882.1890	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11467	Electroencephalograph	An electrically-powered device designed for noninvasive recording of the electrical activity of the brain for display in the form of a graph [electroencephalogram (EEG)], typically to study a variety of neurological conditions, evaluate psychiatric disorders, and/or assist in localizing tumours or lesions on or near the surface of the brain. It is designed to acquire electrical signals from electrodes typically attached to the scalp and ear lobes. The results may be displayed via print-out or electronically; data interpretation and/or telemetry features may also be included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840067100080	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K133355	000