MAX-24
GUDID 00817770020189
OXYGEN SENSOR
MAXTEC, LLC
Respiratory oxygen sensor| Primary Device ID | 00817770020189 |
| NIH Device Record Key | 65d2e5fe-ce4f-4f79-8074-272e3905d8cd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MAX-24 |
| Version Model Number | R109P15 |
| 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 | false |
| Serial Number | true |
| 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 | 00817770020189 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K972992
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 | 2016-09-24 |
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 |
Trademark Results [MAX-24]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAX-24 73815784 1589801 Dead/Cancelled |
WESTERN STATES OPTICAL, INC. 1989-07-31 |
 MAX-24 73791901 1577028 Dead/Cancelled |
WESTERN STATES OPTICAL, INC. 1989-04-07 |
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