FDA Registration
Active
🇺🇸 United States
PRODIGY DIABETES CARE, LLC
Reg #: 3008789114
·
FEI: 3008789114
·
Expires 2026
Products
12
Proprietary Names
23
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- PRODIGY DIABETES CARE, LLC
- Registration Number
- 3008789114
- FEI Number
- 3008789114
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 11621 Patterson Road, Suite 230
- City
- Huntersville
- State
- NC
- ZIP
- 28078
- Country
- US
Regulatory Submissions
- 510(k) Number
- K220475
Owner / Operator
- Firm Name
- Prodigy Diabetes Care, LLC
- Operator Number
- 10033726
- Address
- 11621 Patterson Road, Suite 230
- City
- Huntersville
- State
- NC
- Postal Code
- 28078
- Country
- US
- Correspondent
- Randy Byrd
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | Class 2 | General, Plastic Surgery | No | 2023-04-26 |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | Class 2 | General, Plastic Surgery | No | 2023-04-26 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2019-11-20 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2019-11-20 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2019-11-20 |
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | QUG | Class 2 | Ear, Nose, Throat | No | 2025-07-01 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2016-03-18 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2016-03-18 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2011-04-28 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2023-04-26 |
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2011-12-08 |
| Syringe, Antistick | MEG | Class 2 | General Hospital | No | 2016-11-21 |
Proprietary Names
Prodigy Twist Top Lancets
Prodigy Adjustable Depth Lancing Device
Prodigy Twist Top Lancet
OKB OTC hearing aid GV-SA3.60
Prodigy Preferred Blood Glucose Monitoring System
Prodigy Insulin Syringes
PRODIGY Astro PRO Blood Glucose Monitoring System
PRODIGY Astro PRO Blood Glucose Test Strips
PRODIGY Astro Blood Glucose Monitoring System
Prodigy AutoCode Blood Glucose Monitoring System
Prodigy Voice Blood Glucose Monitoring System
Prodigy No Coding Blood Glucose Test Strips
Prodigy No Coding Blood Glucose Test Strips Arriva Medical
Prodigy Pocket Blood Glucose Monitoring System
Prodigy AutoCode Blood Glucose Monitoring System Arriva Medical
DDI Ultrasonic Nebulizer System
Prodigy Pressure Activated Safety Lancet
Count A Dose
UniStrip Glucose Control Solution
Prodigy Diabetes Management Software
Prodigy Control Solution
Prodigy Blood Glucose Monitoring System
Prodigy Choice Blood Glucose Monitoring System
Establishment Types
Complaint File Establishment per 21 CFR 820.198