Oxus / GCE

GUDID 00867460000106

Zen-O™ Portable Oxygen Concentrator

OXUS AMERICA, INC.

Portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator

• Primary Device ID: 00867460000106
• NIH Device Record Key: dfcc066e-a928-4edb-a6c9-47207ef954f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oxus / GCE
• Version Model Number: RS-00500
• Company DUNS: 962894098
• Company Name: OXUS AMERICA, 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: true
• 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: 248-475-0925
• Email: rlenarcic@oxusamerica.com
• Phone: 248-475-0925
• Email: rlenarcic@oxusamerica.com
• Phone: 248-475-0925
• Email: rlenarcic@oxusamerica.com
• Phone: 248-475-0925
• Email: rlenarcic@oxusamerica.com
• Phone: 248-475-0925
• Email: rlenarcic@oxusamerica.com
• Phone: 248-475-0925
• Email: rlenarcic@oxusamerica.com
• Phone: 248-475-0925
• Email: rlenarcic@oxusamerica.com
• Phone: 248-475-0925
• Email: rlenarcic@oxusamerica.com
• Phone: 248-475-0925
• Email: rlenarcic@oxusamerica.com
• Phone: 248-475-0925
• Email: rlenarcic@oxusamerica.com
• Phone: 248-475-0925
• Email: rlenarcic@oxusamerica.com
• Phone: 248-475-0925
• Email: rlenarcic@oxusamerica.com
• Phone: 248-475-0925
• Email: rlenarcic@oxusamerica.com
• Phone: 248-475-0925
• Email: rlenarcic@oxusamerica.com
• Phone: 248-475-0925
• Email: rlenarcic@oxusamerica.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867460000106 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073242

FDA Product Code

• CAW: Generator, Oxygen, Portable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-30
• Device Publish Date: 2015-07-07

On-Brand Devices [Oxus / GCE]

• 00867460000144: Zen-O™ Clarity Portable Oxygen Concentrator
• 00867460000137: Zen-O Lite Portable Oxygen Concentrator
• 00867460000106: Zen-O™ Portable Oxygen Concentrator