| Primary Device ID | 08809301162194 |
| NIH Device Record Key | f43af2e6-12c2-42b4-93d6-987848e02159 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pip Control Solution Low |
| Version Model Number | PC001-US |
| Company DUNS | 690184887 |
| Company Name | PHILOSYS Co., Ltd |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809301162194 [Primary] |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-21 |
| Device Publish Date | 2020-09-11 |
| 08809301160862 - Pip Blood Glucose Monitoring System | 2020-09-21 |
| 08809301161777 - Pip Blood Glucose Test Strips | 2020-09-21 |
| 08809301162194 - Pip Control Solution Low | 2020-09-21 |
| 08809301162194 - Pip Control Solution Low | 2020-09-21 |
| 08809301162200 - Pip Control Solution Normal | 2020-09-21 |
| 08809301162217 - Pip Control Solution High | 2020-09-21 |