FDA UDI
In Commercial Distribution
🇺🇸 United States
MAXO2 ME
DI: 00853061006951
·
Model: R230P01
·
MAXTEC, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MAXO2 ME
- Primary DI
- 00853061006951
- Version / Model
- R230P01
- Catalog Number
- R230P01
- Company Name
- MAXTEC, LLC
- Labeler DUNS
- 169911828
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-05
- Public Version
- 4
- Public Version Date
- 2018-12-21
- Public Version Status
- Update
- Public Device Record Key
- 09bacd53-f024-46f9-a300-51c00a7596bf
Device Description
AIr/Oxygen Medical Gas Monitor
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | Anesthesiology | 868.1720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35219 | Respiratory oxygen monitor, line-powered | A mains electricity (AC-powered) instrument designed to continuously measure the concentration of oxygen (O2) inspired by a patient in a respiratory maintenance/therapy setting (e.g., O2 in an anaesthesia or ventilator breathing circuit, oxygen tent, oxygen therapy device/system tubing). It typically consists of an electronic unit with a display to show actual values of percentage of O2 concentration, a sensor to detect the O2 values, control knobs or buttons, and an alarm to alert when O2 values are beyond a predetermined range; it may also include appropriate temperature-compensated electrodes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853061006951 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153659 | 000 |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 800 – 1013 millibar
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 122 Degrees Fahrenheit