MaxVenturi R211P03-124

GUDID 00817770025658

International MaxVenturi with Pole Clamp and DISS Fitting

MAXTEC, LLC

Respiratory oxygen monitor, battery-powered Respiratory oxygen monitor, battery-powered Respiratory oxygen monitor, battery-powered Respiratory oxygen monitor, battery-powered Respiratory oxygen monitor, battery-powered Respiratory oxygen monitor, battery-powered Respiratory oxygen monitor, battery-powered Respiratory oxygen monitor, battery-powered Respiratory oxygen monitor, battery-powered Respiratory oxygen monitor, battery-powered Respiratory oxygen monitor, battery-powered Respiratory oxygen monitor, battery-powered Respiratory oxygen monitor, battery-powered Respiratory oxygen monitor, battery-powered Respiratory oxygen monitor, battery-powered Respiratory oxygen monitor, battery-powered Respiratory oxygen monitor, battery-powered

• Primary Device ID: 00817770025658
• NIH Device Record Key: b710f7fd-2b09-44e2-a93d-acbfd4e0c8fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MaxVenturi
• Version Model Number: International DISS
• Catalog Number: R211P03-124
• 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: true
• 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	00817770025658 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063488

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: 2023-06-16
• Device Publish Date: 2023-06-08

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