FDA UDI
In Commercial Distribution
🇺🇸 United States
Bovie®
DI: 10607151005914
·
Model: BV-HGS
·
BOVIE MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bovie®
- Primary DI
- 10607151005914
- Version / Model
- BV-HGS
- Catalog Number
- BV-HGS
- Company Name
- BOVIE MEDICAL CORPORATION
- Labeler DUNS
- 079940465
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-03
- Public Version
- 3
- Public Version Date
- 2020-05-14
- Public Version Status
- Update
- Public Device Record Key
- 88f227eb-575c-4c74-b4ac-804cd84dbc14
Device Description
BOVIE HELIUM GAS REGULATOR
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 |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60328 | Calibration 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 an calibration gas cylinder to lower high, variable gas pressure to a lower, constant working pressure, and may provide a pre-set flow rate of calibration gas for calibration of e.g., an anaesthesia monitor. 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, usually a manometer or manometers, to display the available gas reserve of a gas cylinder and the working pressure. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10607151005914 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 75 Percent (%) Relative Humidity