| Primary Device ID | 00384842533507 |
| NIH Device Record Key | 96bfc6b7-4dfd-478f-a193-8f6b97b33892 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Prodigy Control Solution High |
| Version Model Number | 053350 |
| Catalog Number | 053350 |
| 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 | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00384840533509 [Primary] |
| GS1 | 00384842533507 [Package] Contains: 00384840533509 Package: Corrugated Carton [1000 Units] In Commercial Distribution |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| 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 | 2016-09-22 |
| 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) |
| 00384840832251 - Prodigy Adjustable Depth Lancing Device | 2018-09-21 Prodigy Adjustable Depth Lancing Device |