Analyzer R217P62-008

GUDID 00817770025948

Analyzer, MaxO2+ Inspirational Healthcare

MAXTEC, LLC

Respiratory oxygen monitor, line-powered

• Primary Device ID: 00817770025948
• NIH Device Record Key: ebbd0427-db7d-405b-956d-0ffeccd207df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Analyzer
• Version Model Number: MaxO2+
• Catalog Number: R217P62-008
• Company DUNS: 169911828
• Company Name: MAXTEC, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817770025948 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-22
• Device Publish Date: 2024-08-14

On-Brand Devices [Analyzer]

• 00817770025948: Analyzer, MaxO2+ Inspirational Healthcare
• 00817770025931: Analyzer, MaxO2+A with Low Flow 15 LPM BlenderBuddy2
• 00817770025849: Analyzer, MaxO2+ A with 60 PSI BlenderBuddy