Cascade IOMAX Intraoperative Monitor

Basic Information

• Brand Name: Cascade IOMAX Intraoperative Monitor
• Primary DI: 00840067102763
• Version / Model: 190309-200
• Company Name: CADWELL INDUSTRIES, INC.
• Labeler DUNS: 098554157
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-31
• Public Version: 2
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 4f34586d-9064-4dc5-99ab-de4c1487b2c5

Device Description

IOMAX 32 Channel Amplifier

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
IKN	Electromyograph, diagnostic	Physical Medicine	890.1375	2
GWQ	Full-montage Standard Electroencephalograph	Neurology	882.1400	2
GWJ	STIMULATOR, AUDITORY, EVOKED RESPONSE	Neurology	882.1900	2
GZO	Device, galvanic skin response measurement	Neurology	882.1540	2
JXE	DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT	Neurology	882.1550	2
DQA	Oximeter	Cardiovascular	870.2700	2
GWF	STIMULATOR, ELECTRICAL, EVOKED RESPONSE	Neurology	882.1870	2
GWE	Stimulator, photic, evoked response	Neurology	882.1890	2
OLT	Non-normalizing quantitative electroencephalograph software	Neurology	882.1400	2
ETN	STIMULATOR, NERVE	Ear, Nose, Throat	874.1820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11474	Electromyograph	An electrically-powered unit designed for the measurement and recording of the intrinsic electrical potential of skeletal muscle for display in the form of a graph [electromyograph (EMG)], typically for diagnosis of muscle and/or nerve disorders. It is designed to receive analogue electrical signals from EMG electrodes and process/digitize these signals for viewing, either on an integrated display or for transmission to an off-the-shelf computer.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840067102763	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K162199	000