PRODIGY CHOICE
PRODIGY DIABETES CARE, LLC
PRODIGY DIABETES CARE, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008789114 | 3008789114 | PRODIGY DIABETES CARE, LLC | 1 | Y | 2026-01-01 | 11621 Patterson Road Suite 230 Huntersville NC US 28078 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 121259 | 1896218480 | K883311 | COUNT-A-DOSE | FMF | 1988-09-15 |
| 121259 | 1644083754 | K223208 | Safety Lancet | FMK | 2023-02-10 |
| 121259 | 1723194919 | K222472 | Lancing System, Sterile Lancet for Single Use, Lancing Device | QRL | 2022-11-30 |
| 121259 | 1434987189 | K220475 | Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) | QRL | 2022-07-06 |
| 121259 | 1454268821 | K152808 | U&U Insulin Syringe with/without Safety Retractable Device | MEG | 2016-03-25 |
| 121259 | 1303927021 | K152599 | PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System | NBW | 2016-07-20 |
| 121259 | 1139615063 | K142785 | PRODIGY iConnect Blood Glucose Monitoring System | NBW | 2015-12-17 |
| 121259 | 1182230285 | K132633 | OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2014-08-14 |
| 121259 | 1053998867 | K122340 | PRODIGY CHOICE | NBW | 2013-11-26 |
| 121259 | 1829197950 | K122338 | PREFERRED BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2013-11-05 |
| 121259 | 1423602962 | K112057 | KDL SYRINGES AND NEEDLE | FMF | 2011-12-14 |
| 121259 | 1437020896 | K103115 | PRODIGY DIABETES MANAGEMENT SOFTWARE | NBW | 2011-10-12 |
| 121259 | 1341542535 | K090609 | OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2010-02-04 |
| 121259 | 1984700142 | K090307 | DDI ULTRASONIC NEBULIZER SYSTEM | CAF | 2009-06-18 |
| 121259 | 1155994149 | K073118 | PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2008-03-05 |
| 121259 | 1994380374 | K063026 | OK METER BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2007-02-09 |
| 121259 | 2032515258 | K060467 | PRODIGY BLOOD GLUCOSE TEST SYSTEM | NBW | 2006-07-13 |
| 121259 | 2059327030 | ||||
| 121259 | 1035015093 | ||||
| 121259 | 1945234289 |
Product Codes Associated With Registrations#
PMN#
PREFERRED BLOOD GLUCOSE MONITORING SYSTEM
PRODIGY DIABETES CARE, LLC
PRODIGY DIABETES MANAGEMENT SOFTWARE
PRODIGY DIABETES CARE, LLC.
GUDID#
Prodigy No Coding Blood Glucose Test Strips - 1 Box of Prodigy No Coding Blood Glucose Test Strips for eCommerce (50 ct)
2024-07-10
Prodigy AutoCode Blood Glucose Monitoring System - Prodigy AutoCode Blood Glucose Monitoring System (KIT)
2016-09-22
Prodigy Voice Blood Glucose Monitoring System - Prodigy Voice Blood Glucose Monitoring System (KIT)
2016-09-22
Prodigy No Coding Blood Glucose Test Strips - 1 Box of Prodigy No Coding Blood Glucose Test Strips (25 ct).
2016-09-21
Prodigy Voice Blood Glucose Monitoring System - Prodigy Voice Blood Glucose Monitoring System (KIT)
2016-09-22
Prodigy No Coding Blood Glucose Test Strips - 1 Box of Prodigy No Coding Blood Glucose Test Strips (50 ct).
2016-09-21
Prodigy No Coding Blood Glucose Test Strips - 1 Box of Prodigy No Coding Blood Glucose Test Strips (50 ct).
2016-09-21
Prodigy iConnect Blood Glucose Monitoring System - 076150
2016-09-23
Prodigy No Coding Blood Glucose Test Strips - 1 Box of Prodigy No Coding Blood Glucose Test Strips (50 ct).
2016-09-21
Prodigy No Coding Blood Glucose Test Strips - 1 Vial of Prodigy No Coding Blood Glucose Test Strips (10 ct).
2016-09-21
Prodigy Combo Pre-Pack - Prodigy Combo Pre-Pack20 x Item # 073200; 5 x Item # 07120
2016-09-21
Prodigy Value Pack - Prodigy Value Pack12 x Item # 073200; 4 x Item # 07120
2016-09-21
Prodigy No Coding Blood Glucose Test Strips - 1 Box of Prodigy No Coding Blood Glucose Test Strips (50 ct).
2016-09-21
PRODIGY ASTRO PRO No Coding Blood Glucose Test Strips - PRODIGY ASTRO PRO No Coding Blood Glucose Test Strips (50 ct)
2020-09-22
Prodigy No Coding Blood Glucose Test Strips - Prodigy No Coding Blood Glucose Test Strips (100 ct) with FREE AutoCode meter.for eCommerce
2024-07-11
Prodigy No Coding Blood Glucose Test Strips - 1 Box of Prodigy No Coding Blood Glucose Test Strips for eCommerce (50 ct)
2024-07-10
Prodigy No Coding Blood Glucose Test Strips - Prodigy No Coding Blood Glucose Test Strips (100 ct) with FREE AutoCode meter.
2019-01-16
Prodigy AutoCode Blood Glucose Monitoring System - Prodigy AutoCode Blood Glucose Monitoring System (Meter Only)
2016-09-21
Prodigy AutoCode Blood Glucose Monitoring System - 070120
2016-09-21
Prodigy Pocket Blood Glucose Monitoring System - 070802
2016-09-21
Prodigy AutoCode Blood Glucose Monitoring System - 074300
2016-11-07
Prodigy Pocket Blood Glucose Monitoring System - Prodigy Pocket Blood Glucose Monitoring System - Blue (KIT)
2016-09-21
Prodigy Control Solution Low - Prodigy Control Solution Low 4mL
2016-09-22
Prodigy Control Solution High - Prodigy Control Solution High 4mL
2016-09-22
Prodigy Pressure Activated Safety Lancets - Prodigy Pressure Activated Safety Lancets 21G (100 ct)
2018-08-21
Prodigy Control Solution Low - Prodigy Control Solution Low 4mL
2016-09-22
Prodigy Pressure Activated Safety Lancets - Prodigy Pressure Activated Safety Lancets 28G (100 ct)
2018-08-21
Prodigy Insulin Syringes - Prodigy Insulin Syringes 31G 8mm 1/2cc
2016-09-22
Prodigy Insulin Syringes - Prodigy Insulin Syringes 31G 8mm 3/10cc
2016-09-22
PRODIGY Astro PRO Blood Glucose Monitoring System - PRODIGY Astro PRO Blood Glucose Monitoring System For Professional Use on Multiple Patients
2020-09-22
Prodigy Pocket Blood Glucose Monitoring System - 050302
2016-09-21
Prodigy Twist Top Lancets - Prodigy Twist Top Lancets 28G (100 ct)
2018-08-21
Prodigy Pressure Activated Safety Lancets - Prodigy Pressure Activated Safety Lancets 26G (100 ct)
2018-08-21
Prodigy Adjustable Depth Lancing Device - 24-083225
2018-08-21
Prodigy Twist Top Lancets - Prodigy Twist Top Lancets 28G (100 ct)
2018-08-20
Prodigy Adjustable Depth Lancing Device - 990355
2018-08-21
Prodigy Insulin Syringes - Prodigy Insulin Syringes 28G 12.7mm 1cc
2016-09-22
Prodigy Insulin Syringes - Prodigy Insulin Syringes 28G 12.7mm 1cc
2016-09-22
Prodigy Insulin Syringes - Prodigy Insulin Syringes 31G 8mm 1/2cc
2016-09-22
Prodigy Insulin Syringes - Prodigy Insulin Syringes 31G 8mm 3/10cc
2016-09-22