| 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 |
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