MAXO2+

GUDID 00817770020943

Analyzer with Optiflow Jr.

MAXTEC, LLC

Respiratory oxygen monitor, line-powered

• Primary Device ID: 00817770020943
• NIH Device Record Key: f3f6c803-47f9-49bc-b27c-d76a63021caa
• Commercial Distribution Discontinuation: 2019-05-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MAXO2+
• Version Model Number: R219P17-003
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817770020943 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040484

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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-07
• Device Publish Date: 2016-09-28

On-Brand Devices [MAXO2+]

• 00817770020967: Analyzer with MicroMax BlenderBuddy 0-15 0-3.5
• 00817770020950: Analyzer with MicroMax BlenderBuddy 0-70 DISS
• 00817770020943: Analyzer with Optiflow Jr.
• 00817770020677: MaxO2+A Analyzer with Adapter
• 00817770020660: Medical A International Analyzer