Oxus Refurbished Sieve Bed

GUDID 00867460000120

Inogen One G3 Replacement Sieve Beds

OXUS AMERICA, INC.

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

• Primary Device ID: 00867460000120
• NIH Device Record Key: 02f09c09-57e4-4ed8-b367-eb64ee2688bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oxus Refurbished Sieve Bed
• Version Model Number: RS-07001/RS-07002
• 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: 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: 2487090490
• Email: rlenarcic@oxusamerica.com
• Phone: 2487090490
• Email: rlenarcic@oxusamerica.com
• Phone: 2487090490
• Email: rlenarcic@oxusamerica.com
• Phone: 2487090490
• Email: rlenarcic@oxusamerica.com
• Phone: 2487090490
• Email: rlenarcic@oxusamerica.com
• Phone: 2487090490
• Email: rlenarcic@oxusamerica.com
• Phone: 2487090490
• Email: rlenarcic@oxusamerica.com
• Phone: 2487090490
• Email: rlenarcic@oxusamerica.com
• Phone: 2487090490
• Email: rlenarcic@oxusamerica.com
• Phone: 2487090490
• Email: rlenarcic@oxusamerica.com
• Phone: 2487090490
• Email: rlenarcic@oxusamerica.com
• Phone: 2487090490
• Email: rlenarcic@oxusamerica.com
• Phone: 2487090490
• Email: rlenarcic@oxusamerica.com
• Phone: 2487090490
• Email: rlenarcic@oxusamerica.com
• Phone: 2487090490
• Email: rlenarcic@oxusamerica.com
• Phone: 2487090490
• Email: rlenarcic@oxusamerica.com
• Phone: 2487090490
• Email: rlenarcic@oxusamerica.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867460000120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211056

FDA Product Code

• CAW: Generator, Oxygen, Portable

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-28
• Device Publish Date: 2023-06-20

Devices Manufactured by OXUS AMERICA, INC.

• 00867460000120 - Oxus Refurbished Sieve Bed: 2023-06-28Inogen One G3 Replacement Sieve Beds
• 00867460000120 - Oxus Refurbished Sieve Bed: 2023-06-28 Inogen One G3 Replacement Sieve Beds
• 00867460000106 - Oxus / GCE: 2020-03-30 Zen-O™ Portable Oxygen Concentrator
• 00867460000137 - Oxus / GCE: 2020-03-30 Zen-O Lite Portable Oxygen Concentrator
• 00867460000144 - Oxus / GCE: 2018-04-02 Zen-O™ Clarity Portable Oxygen Concentrator