FDA UDI
In Commercial Distribution
🇺🇸 United States
O-TWO
DI: 07540195060241
·
Model: 01RO01O23-B
·
O-Two Medical Technologies Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- O-TWO
- Primary DI
- 07540195060241
- Version / Model
- 01RO01O23-B
- Company Name
- O-Two Medical Technologies Inc
- Labeler DUNS
- 206449154
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-06
- Public Version
- 1
- Public Version Date
- 2023-06-14
- Public Version Status
- New
- Public Device Record Key
- dd55e54e-5851-4d70-9fd4-b1eef2c28d47
Device Description
Oxygen Regulator
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| CAN | Regulator, Pressure, Gas Cylinder | Anesthesiology | 868.2700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66777 | Non-fixed medical gas distribution line regulator | A reduction valve designed to be attached through a gastight connector (e.g., a pin-index or bull-nosed screw thread connection) to the valve stem of a medical gas (e.g., carbon dioxide, oxygen, nitrous oxide, gas mixture) distribution line to reduce high, variable gas pressure to a lower, constant working pressure (excludes procedure-dedicated valves). It will have a safety relief valve to avoid excessive pressure due to increased ambient temperatures, and it may have associated devices (e.g., a manometer, flowmeter) to display the available gas reserve of a gas cylinder, the working pressure, and/or the flow rate. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07540195060241 | GS1 |
Customer Contacts
- Phone
- 9057926896
- [email protected]