Cascade IOMAX Intraoperative Monitor

Basic Information

• Brand Name: Cascade IOMAX Intraoperative Monitor
• Primary DI: 00840067100646
• Version / Model: 190295-200
• Company Name: CADWELL INDUSTRIES, INC.
• Labeler DUNS: 098554157
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-31
• Public Version: 5
• Public Version Date: 2019-04-15
• Public Version Status: Update
• Public Device Record Key: b7e7a767-ab1b-40ba-a509-b4e4f2bdfe5c

Device Description

Cascade IOMAX Limb Module

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: Yes
• Has Lot/Batch Number: No
• 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
GWF	STIMULATOR, ELECTRICAL, EVOKED RESPONSE	Neurology	882.1870	2
JXE	DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT	Neurology	882.1550	2
GWJ	STIMULATOR, AUDITORY, EVOKED RESPONSE	Neurology	882.1900	2
DQA	Oximeter	Cardiovascular	870.2700	2
ETN	STIMULATOR, NERVE	Ear, Nose, Throat	874.1820	2
IKN	Electromyograph, diagnostic	Physical Medicine	890.1375	2
GZO	DEVICE, GALVANIC SKIN RESPONSE MEASUREMENT	Neurology	882.1540	2
GWQ	Full-montage Standard Electroencephalograph	Neurology	882.1400	2
GWE	Stimulator, photic, evoked response	Neurology	882.1890	2
OLT	Non-normalizing quantitative electroencephalograph software	Neurology	882.1400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46566	Neurophysiologic monitoring system	An assembly of mains electricity (AC-powered) devices designed to monitor and provide electrical stimuli to spinal nerves or other neural pathways (may include the brain) during intraoperative surgery or intensive care, typically to reduce the incidence of accidental injury during instrumented spine surgery, or to diagnose acute dysfunction in corticospinal conduction (e.g., due to traction, shearing, laceration, compression, or vascular insufficiency). It typically displays electroencephalogram (EEG), electromyogram (EMG), and/or evoked responses. It typically includes an electric current pulse generator, electrodes and/or probes, and audible and/or visual indicators.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840067100646	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K162199	000