MiniOX

GUDID 00628101609153

Oxygen Monitor

OHIO MEDICAL, LLC

Respiratory oxygen monitor, battery-powered

• Primary Device ID: 00628101609153
• NIH Device Record Key: d3523feb-3a0f-4838-b88e-157352ae62b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MiniOX
• Version Model Number: MINIOX 3000
• Company DUNS: 005192885
• Company Name: OHIO MEDICAL, LLC
• 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: 18478550500
• Email: customer.service@ohiomedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628101609153 [Primary]
GS1	08688250002153 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961644

FDA Product Code

• CCL: Analyzer, Gas, Oxygen, Gaseous-Phase

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: 2020-05-08
• Device Publish Date: 2020-04-30

On-Brand Devices [MiniOX]

• 08688250002566: Oxygen Analyzer with Sensor
• 08688250002559: Oxygen Monitor with Sensor
• 08688250002542: Oxygen Analyzer with Sensor
• 08688250002214: Oxygen Analyzer
• 08688250002184: Oxygen Analyzer
• 08688250002153: Oxygen Monitor
• 00628101609481: Oxygen Analyzer with Sensor
• 00628101609474: Oxygen Monitor with Sensor
• 00628101609467: Oxygen Analyzer with Sensor
• 00628101609207: Oxygen Analyzer
• 00628101609184: Oxygen Analyzer
• 00628101609153: Oxygen Monitor