MAXVENTURI

GUDID 00817770021148

MaxVenturi Muffler

MAXTEC, LLC

Respiratory oxygen monitor, battery-powered

• Primary Device ID: 00817770021148
• NIH Device Record Key: d2c23bd5-3a84-44ac-bb10-560148ec16ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAXVENTURI
• Version Model Number: R211P38
• 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	00817770021148 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-01-14
• Device Publish Date: 2016-11-09

On-Brand Devices [MAXVENTURI]

• 00817770021148: MaxVenturi Muffler
• 00817770021131: MaxVenturi with Max-250E Sensor and DISS Fitting
• 00817770020981: Carefusion Private Label
• 00853061006296: DISS, Pole Clamp, Teleflex Private Label
• 00817770020905: High Flow, Pole Clamp
• 00817770020899: NIST Fitting, High Flow
• 00817770020882: MAXVENTURI, (SPANISH) LOCKING POLE CLAMP
• 00817770020820: MaxVenturi with Pole Clamp and Nut/Nipple DISS Fitting
• 00817770020509: MaxVenturi High Flow with Locking Pole Clamp and NIST Fitting
• 00817770020493: MaxVenturi High Flow with Pole Clamp and DISS Fitting
• 00817770020486: MaxVenturi International Dextro Labeled with DISS Fitting
• 00817770020479: MaxVenturi International with Locking Pole Clamp and Nut/Nipple DISS Fitting
• 00817770020462: MaxVenturi International with Pole Clamp and Nut/Nipple DISS Fitting
• 00817770020455: MaxVenturi with Locking Pole Clamp and Nut/Nipple DISS Fitting
• 00817770020448: MaxVenturi International with Locking Pole Clamp and NIST Fitting
• 00817770020431: MaxVenturi International with Locking Pole Clamp and DISS Fitting
• 00817770020424: MaxVenturi International with Pole Clamp and NIST Fitting
• 00817770020417: MaxVenturi International with Pole Clamp and DISS Fitting
• 00817770020400: MaxVenturi Locking Pole Clamp NIST Fitting
• 00817770020394: MaxVenturi with Locking Pole Clamp and DISS Fitting
• 00817770020387: MaxVenturi with Pole Clamp and NIST Fitting
• 00817770020370: MaxVenturi with Pole Clamp and DISS Fitting
• 00817770025689: Venturi Muffler
• 00817770025658: International MaxVenturi with Pole Clamp and DISS Fitting