FDA UDI
In Commercial Distribution
🇺🇸 United States
ISA™ OR+
DI: 07350046131828
·
Model: OR+ ROOT
·
Masimo Sweden AB
Product Codes
8
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ISA™ OR+
- Primary DI
- 07350046131828
- Version / Model
- OR+ ROOT
- Company Name
- Masimo Sweden AB
- Labeler DUNS
- 632369067
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-11
- Public Version
- 5
- Public Version Date
- 2021-12-06
- Public Version Status
- Update
- Public Device Record Key
- 009c3e40-ca11-465a-a6e2-5a50bece9830
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 |
| NHQ | Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | Anesthesiology | 868.1500 | 2 |
| NHP | Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | Anesthesiology | 868.1500 | 2 |
| NHO | Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | Anesthesiology | 868.1500 | 2 |
| CBS | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | Anesthesiology | 868.1620 | 2 |
| CBR | Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | Anesthesiology | 868.1700 | 2 |
| CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | Anesthesiology | 868.1500 | 2 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Anesthesiology | 868.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37061 | Patient monitoring system module, multiple-gas | A small unit dedicated to the measurement of various gas concentrations, e.g., anaesthetic agents, oxygen (O2), carbon dioxide (CO2), in inspired and expired air obtained through a sampling tube connected to a main respiratory channel (mainstream) or a side-channel (sidestream) of a breathing circuit. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot and the parent device then operates as a mainframe computer displaying the parameters measured and provided by this module. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07350046131828 | GS1 |