FLOCAP

GUDID 00817770020813

MAXTEC, LLC

Exhaled-gas oesophageal intubation detector, adult

• Primary Device ID: 00817770020813
• NIH Device Record Key: ac5fab79-b378-4a79-8108-adf1c123f438
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLOCAP
• Version Model Number: R500P23
• 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: true
• 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	00817770020813 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133540

FDA Product Code

• CCK: Analyzer, Gas, Carbon-Dioxide, 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: 2019-12-23
• Device Publish Date: 2016-09-27

Devices Manufactured by MAXTEC, LLC

• 00817770025665 - Oxygen Sensor: 2024-08-22 Sensor, Max-250E Oxygen Taiwan
• 00817770025849 - Analyzer: 2024-08-22 Analyzer, MaxO2+ A with 60 PSI BlenderBuddy
• 00817770025856 - MaxBlend2: 2024-08-22 MaxBlend2, High Flow 0-15 LPM DISS 50 PSI
• 00817770025863 - Manifold: 2024-08-22 Manifold, Acrylic 0-70 White Nist 660 PSI
• 00817770025870 - Manifold: 2024-08-22 Manifold, Acrylic 0-70 White DISS 60 PSI F&P
• 00817770025931 - Analyzer: 2024-08-22 Analyzer, MaxO2+A with Low Flow 15 LPM BlenderBuddy2
• 00817770025948 - Analyzer: 2024-08-22 Analyzer, MaxO2+ Inspirational Healthcare
• 00817770025955 - Manifold: 2024-08-22 Manifold, Acrylic 0-70 Dual Qhite Aust 60 PSI F&P