UltraMax

GUDID 00817770020936

ULTRAMAX, INTERNATIONAL ANALYZER

MAXTEC, LLC

Respiratory oxygen monitor, battery-powered

• Primary Device ID: 00817770020936
• NIH Device Record Key: 894a18a4-3a8a-4128-9b3f-6ba11e47945a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraMax
• Version Model Number: R221P11-001
• Company DUNS: 169911828
• Company Name: MAXTEC, 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817770020936 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112402

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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-27

On-Brand Devices [UltraMax]

• 00817770020936: ULTRAMAX, INTERNATIONAL ANALYZER
• 00817770020929: OXYGEN ANALYZER, ULTRAMAX