NA

GUDID 00817492021815

Ozone System

MAR COR PURIFICATION, INC.

Ozone generator, stationary

• Primary Device ID: 00817492021815
• NIH Device Record Key: fd4d5372-ee8b-4d03-a338-ffdfb3631533
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: GENERATOR,O3Z-E,0-4GM/HR
• Catalog Number: NA
• Company DUNS: 019056181
• Company Name: MAR COR PURIFICATION, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8006333080
• Email: info@mcpur.com
• Phone: 8006333080
• Email: info@mcpur.com
• Phone: 8006333080
• Email: info@mcpur.com

Device Dimensions

• Width: 10 Inch
• Width: 10 Inch
• Width: 10 Inch
• Width: 10 Inch
• Width: 10 Inch
• Width: 10 Inch
• Width: 10 Inch
• Width: 10 Inch
• Width: 10 Inch
• Width: 10 Inch
• Width: 10 Inch
• Width: 10 Inch

Operating and Storage Conditions

• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817492021815 [Primary]

FDA Product Code

• NII: Disinfectant, Dialysate Delivery System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-04-06

Devices Manufactured by MAR COR PURIFICATION, INC.

• 00817492022553 - BioPure 4400 RO: 2021-10-21 RO, 4400M-12K, 208V, 1PH, 60HZ, 75% RCV, ST (4400M-12K RO Machine, 12,000 GPD, 208Volts, 1-Phase, 60 Hertz, 75% Recovery, Storag
• 00817492022546 - EON: 2021-03-02
• 00817492022522 - BioPure HX2: 2021-02-26 RO/BIOPURE HX2P-11GPM/460V/3PH/60HZ/DL
• 00817492022539 - BioPure HX2: 2021-02-26 RO/BIOPURE HX2P-11GPM/208V/3PH/60HZ/DL
• 00817492022454 - Millenium HX: 2020-05-01 RO,Millenium HX, 750GPD,4118,115~,60HZ
• 00817492022478 - Millenium HX: 2020-05-01 RO,Millenium HX, 750GPD,4118,230~,50HZ
• 00817492022409 - BioPure Portable RO: 2019-03-11
• 00817492022072 - BioPure 4400 RO: 2019-03-04