GCE

GUDID 08592346904156

Zen-O™ Portable Oxygen Concentrator

GAS CONTROL EQUIPMENT LIMITED

Mobile/portable oxygen concentrator

• Primary Device ID: 08592346904156
• NIH Device Record Key: 35392c9b-1218-4cb0-8e45-4bbfcafc0d0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GCE
• Version Model Number: RS-00500
• Company DUNS: 296797616
• Company Name: GAS CONTROL EQUIPMENT LIMITED
• 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: 847-855-6318
• Email: Jessica.Barrile@ohiomedical.com
• Phone: 847-855-6318
• Email: Jessica.Barrile@ohiomedical.com
• Phone: 847-855-6318
• Email: Jessica.Barrile@ohiomedical.com
• Phone: 847-855-6318
• Email: Jessica.Barrile@ohiomedical.com
• Phone: 847-855-6318
• Email: Jessica.Barrile@ohiomedical.com
• Phone: 847-855-6318
• Email: Jessica.Barrile@ohiomedical.com
• Phone: 847-855-6318
• Email: Jessica.Barrile@ohiomedical.com
• Phone: 847-855-6318
• Email: Jessica.Barrile@ohiomedical.com
• Phone: 847-855-6318
• Email: Jessica.Barrile@ohiomedical.com
• Phone: 847-855-6318
• Email: Jessica.Barrile@ohiomedical.com
• Phone: 847-855-6318
• Email: Jessica.Barrile@ohiomedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08592346904156 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162433

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: 2024-04-29
• Device Publish Date: 2024-04-19

On-Brand Devices [GCE]

• 08592346679832: Zen-O™ Clarity Portable Oxygen Concentrator
• 08592346658110: Zen-O Lite Portable Oxygen Concentrator
• 08592346004337: Zen-O™ Portable Oxygen Concentrator
• 05060456420000: Zen-O Lite Clarity Portable Oxygen Concentrator
• 08592346904156: Zen-O™ Portable Oxygen Concentrator
• 08592346805477: ZenO Lite Portable Oxygen Concentrator