| Primary Device ID | G212HP20401 |
| NIH Device Record Key | eb10ea0e-9822-49a6-8d54-cc8caa8e1728 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Peracid Test |
| Version Model Number | HP20401 |
| Company DUNS | 016808871 |
| Company Name | Ibt Scientific 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 | true |
| 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 |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | G212HP20401 [Primary] |
| FKP | System, Dialysate Delivery, Single Patient |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-04-16 |
| Device Publish Date | 2022-01-06 |
| G212WS20301 - WaterSoft | 2025-12-22 1 bottle of 100 test strips to test water hardness |
| G212WS21350 - WaterSoft 0-30 | 2025-12-22 1 bottle of 50 test strips to test water hardness |
| G212HP20401 - Peracid Test | 2024-04-161 bottle of 100 test strips to detect peracetic acid |
| G212HP20401 - Peracid Test | 2024-04-16 1 bottle of 100 test strips to detect peracetic acid |