FDA Registration
Active
🇺🇸 United States
TRIBALCO
Reg #: 3010317211
·
FEI: 3010317211
·
Expires 2026
Products
18
Proprietary Names
16
Establishment Types
1
Classifications
18
Registration Details
- Registration Name
- TRIBALCO
- Registration Number
- 3010317211
- FEI Number
- 3010317211
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1802 Grant St Ste 300
- City
- Tampa
- State
- FL
- ZIP
- 33605
- Country
- US
Regulatory Submissions
- 510(k) Number
- K232107
Owner / Operator
- Firm Name
- Tribalco
- Operator Number
- 10044850
- Address
- 1802 Grant St, Suite 300
- City
- Tampa
- State
- FL
- Postal Code
- 33605
- Country
- US
- Correspondent
- Patricia H Becker
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Warmer, Thermal, Infusion Fluid | LGZ | Class 2 | General Hospital | No | 2026-02-20 |
| Warmer, Blood, Non-Electromagnetic Radiation | BSB | Class 2 | Hematology | No | 2026-02-20 |
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2023-12-14 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2022-12-23 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2022-12-23 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2022-12-23 |
| Dc-Defibrillator, Low-Energy, (Including Paddles) | LDD | Class 2 | Cardiovascular | No | 2022-12-23 |
| Automated External Defibrillators (Non-Wearable) | MKJ | Class 3 | Cardiovascular | No | 2022-12-23 |
| Aid, Cardiopulmonary Resuscitation | LIX | Class 2 | Cardiovascular | No | 2022-12-23 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2022-12-23 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2022-12-23 |
| Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | DRO | Class 2 | Cardiovascular | No | 2022-12-23 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2021-12-15 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2013-08-08 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2013-08-08 |
| System, Thermal Regulating | DWJ | Class 2 | Cardiovascular | No | 2021-12-15 |
| Generator, Oxygen, Portable | CAW | Class 2 | Anesthesiology | No | 2013-08-08 |
| Chamber, Hyperbaric | CBF | Class 2 | Anesthesiology | No | 2020-01-13 |
Proprietary Names
MEQU Warmer System
Ventway Sparrow
Zoll Propaq MD
C MAC 8403 Video Laryngoscope
RAD 57
Thermometer
Model 9550, Onyx II; Model 9570; Model 9571; Model 9590; Onyx Vantage
Monitor
TEMPUS PRO PATIENT MONITOR
Geratherm Mini Rescue II R130
Generator
SAROS Oxygen System Model 3000
The Belmont buddy lite Blood/Fluid Warmer; The Belmont buddy lite Fluid Warmer
ZOLL AED PRO
CHAMBERLITE; GAMOW; OASIS; RESPIRO; SOLACE; VITAERIS
EMMA Phasein
Establishment Types
Repack or Relabel Medical Device