| Primary Device ID | 00384843761503 |
| NIH Device Record Key | 4c77ca17-2a7c-430f-b27a-406b168ab600 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Prodigy iConnect Blood Glucose Monitoring System |
| Version Model Number | 076150 |
| Catalog Number | 076150 |
| Company DUNS | 832875905 |
| Company Name | PRODIGY DIABETES CARE, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | true |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00384840761506 [Primary] |
| GS1 | 00384843761503 [Package] Contains: 00384840761506 Package: Corrugated Carton [10 Units] In Commercial Distribution |
| CGA | Glucose Oxidase, Glucose |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-23 |
| 00384840517004 - PRODIGY ASTRO PRO No Coding Blood Glucose Test Strips | 2025-03-06 PRODIGY ASTRO PRO No Coding Blood Glucose Test Strips (50 ct) |
| 00384843104003 - Prodigy No Coding Blood Glucose Test Strips | 2024-07-18 1 Box of Prodigy No Coding Blood Glucose Test Strips for eCommerce (50 ct) |
| 30384840517005 - PRODIGY PRO No Coding Blood Glucose Test Strips | 2020-09-30 PRODIGY PRO No Coding Blood Glucose Test Strips (50 ct) Individually Wrapped Foil Packs for Professional Use |
| 00384840517752 - PRODIGY Astro PRO Blood Glucose Monitoring System | 2020-09-30 PRODIGY Astro PRO Blood Glucose Monitoring System For Professional Use on Multiple Patients |
| 00384841732000 - Prodigy No Coding Blood Glucose Test Strips | 2019-02-18 Prodigy No Coding Blood Glucose Test Strips (100 ct) with FREE AutoCode meter. |
| 00384840810280 - Prodigy Twist Top Lancets | 2018-09-21 Prodigy Twist Top Lancets 28G (100 ct) |
| 00384840823167 - Prodigy Pressure Activated Safety Lancets | 2018-09-21 Prodigy Pressure Activated Safety Lancets 26G (100 ct) |
| 30384840823410 - Prodigy Pressure Activated Safety Lancets | 2018-09-21 Prodigy Pressure Activated Safety Lancets 21G (100 ct) |