| Primary Device ID | 10814963021302 |
| NIH Device Record Key | bc9126c0-ce28-4d7b-8ebf-36befcf07e3e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 30% Acetic Acid Solution |
| Version Model Number | R-300 |
| Catalog Number | R-300 |
| Company DUNS | 933721433 |
| Company Name | ROCKWELL MEDICAL, INC. |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814963021305 [Primary] |
| GS1 | 10814963021302 [Package] Contains: 00814963021305 Package: case [4 Units] In Commercial Distribution |
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-06-13 |
| 00814963021503 - CitraPure | 2025-08-05 |
| 00814963021497 - Dri-Sate | 2025-02-14 |
| 10814963020732 - CitraPure | 2024-04-26 |
| 10814963021487 - RenalPure | 2019-06-25 |
| 00814963020001 - Sterilyte | 2018-07-06 |
| 00814963020018 - Sterilyte | 2018-07-06 |
| 00814963020025 - RenalPure | 2018-07-06 |
| 00814963020032 - RenalPure | 2018-07-06 |