FDA Registration
Active
🇺🇸 United States
GROMAN INC.
Reg #: 3004361444
·
FEI: 3004361444
·
Expires 2026
Products
6
Proprietary Names
9
Establishment Types
4
Classifications
6
Registration Details
- Registration Name
- GROMAN INC.
- Registration Number
- 3004361444
- FEI Number
- 3004361444
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2000 Banks Rd Ste G1
- City
- Coconut Creek
- State
- FL
- ZIP
- 33063
- Country
- US
Regulatory Submissions
- 510(k) Number
- K030292
Owner / Operator
- Firm Name
- GROMAN INC.
- Operator Number
- 9054890
- Address
- 4900 NW 15TH ST., STE 4494, --
- City
- Pompano Beach
- State
- FL
- Postal Code
- 33063
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2021-05-12 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 2021-05-12 |
| Airbrush | KOJ | Class 2 | Dental | No | 2007-12-04 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2023-01-17 |
| Lamp, Surgical | FTD | Class 2 | General, Plastic Surgery | No | 2020-01-27 |
| Mask, Oxygen, Low Concentration, Venturi | BYF | Class 1 | Anesthesiology | No | 2021-05-12 |
Proprietary Names
SafetyO2
Standard Jet Nebulizer for SafetyNeb
SafetyFilta
PrepMaster
EtchMaster
ProphyMaster
PowderMaster
CircuitGlow
SafetyNeb
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)