FDA UDI
In Commercial Distribution
🇺🇸 United States
QualityREG
DI: 04251411705893
·
Model: DM-ISO-MS-NIST-CO2
·
DEHAS Medical Systems GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- QualityREG
- Primary DI
- 04251411705893
- Version / Model
- DM-ISO-MS-NIST-CO2
- Catalog Number
- DM-ISO-MS-NIST-CO2
- Company Name
- DEHAS Medical Systems GmbH
- Labeler DUNS
- 343728657
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-08
- Public Version
- 3
- Public Version Date
- 2024-05-16
- Public Version Status
- Update
- Public Device Record Key
- f31b54ed-1d57-4167-9a78-be6030883350
Device Description
QualityREG CO2 Pressure Regulator, Connection ISO 5145, NIST incl. Pressure gauge
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 43438 | Non-fixed medical gas cylinder 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) cylinder to reduce high, variable gas pressure to a lower, constant working pressure (excludes procedure-dedicated valves). It can be a single or a dual stage regulator, usually of a piston or diaphragm design. 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 | 04251411705893 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Minus 20° Celsius to +60° Celsius