FDA Registration
Active
🇺🇸 United States
Trividia Health, Inc.
Reg #: 1000113657
·
FEI: 1000113657
·
Expires 2026
Products
10
Proprietary Names
28
Establishment Types
4
Classifications
10
Registration Details
- Registration Name
- Trividia Health, Inc.
- Registration Number
- 1000113657
- FEI Number
- 1000113657
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2400 NW 55TH CT
- City
- Fort Lauderdale
- State
- FL
- ZIP
- 33309
- Country
- US
Regulatory Submissions
- 510(k) Number
- K220370
Owner / Operator
- Firm Name
- TRIVIDIA HEALTH, INC.
- Operator Number
- 9000560
- Address
- 2400 N.W. 55TH CT., --
- City
- Ft Lauderdale
- State
- FL
- Postal Code
- 33309
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2022-06-01 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2004-02-27 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2006-09-27 |
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2012-11-28 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2013-11-22 |
| Glucose Dehydrogenase, Glucose | LFR | Class 2 | Clinical Chemistry | No | 2013-11-22 |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | Class 2 | General, Plastic Surgery | No | 2022-07-11 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | Class 2 | General, Plastic Surgery | No | 2022-07-11 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2012-05-14 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2019-02-11 |
Proprietary Names
TRUEplus
Leader
Good Neighbor Pharmacy
TopCare
Rite Aid
McKesson
CVS
Sunmark
Lancets
Lancing Device
Gentle Draw
TRUEdraw
Walgreens
Kroger
TRUEmanager
SmartData
TRUENESS AIR
TRUENESS
TRUEfocus
TRUEfocus PRO
TRUE METRIX
TRUE METRIX GO
TRUE METRIX PRO Professional Monitoring Blood Glucose System
TRUE METRIX Self Monitoring Blood Glucose System
TRUEPLUS
HealthMart
TRUE METRIX AIR
McKesson Med Surg
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility