NA

Basic Information

• Brand Name: NA
• Primary DI: 00817492021297
• Version / Model: GENERATOR,O3Z,2.3GM/H
• Company Name: MAR COR PURIFICATION, INC.
• Labeler DUNS: 019056181
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-08-31
• Public Version Status: Update
• Public Device Record Key: 8a35f8ce-7513-4095-a194-6a4ca308cc7a

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: 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
NII	Disinfectant, Dialysate Delivery System	Gastroenterology, Urology	876.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46088	Ozone generator, stationary	A fixed-location, mains electricity (AC-powered) device used to create and deliver ozone (O3) - also known as trioxygen. It typically produces a high electrical voltage between electrodes, to convert room air, or oxygen (O2) feed gas, into O3 when passed through the electrode gap. It usually includes measuring devices to determine output O3 concentration, and a mechanism to destroy internally the unused ozone; it is typically used at the site of application because it is not possible to store ozone. O3 has been used for various purposes in the laboratory, to disinfect/purify air and water, and in some clinical treatment of diseases.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817492021297	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Height	21	Inch
Depth	8	Inch
Width	12	Inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 32 – Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 32 – Degrees Fahrenheit