| Primary Device ID | 00814963021404 |
| NIH Device Record Key | 2b2760bb-6c2b-49c0-b4db-455023d90b59 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DriSate |
| Version Model Number | DF-113 |
| Catalog Number | DF-113 |
| 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 | 00814963021404 [Primary] |
| 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 | 2017-11-27 |
| 00814963021404 | DF-113 |
| 00814963021398 | DF-112 |
| 00814963021381 | DF-111 |
| 00814963020698 | DR-250 |
| 00814963020681 | DR-245 |
| 00814963020674 | DR-230 |
| 00814963020667 | DR-210 |
| 00814963020650 | DR-145 |
| 00814963020643 | DR-130 |
| 00814963020636 | DR-120 |
| 00814963020629 | DF-240 |
| 00814963020612 | DF-220 |
| 00814963020605 | DF-140 |
| 00814963020599 | DF-125 |
| 00814963020582 | DF-120 |
| 00814963020575 | DF-115 |
| 00814963020568 | DC-124 |
| 00814963020551 | DC-117 |
| 00814963020544 | DC-116 |
| 00814963020537 | DC-114 |
| 00814963020520 | DC-110 |
| 00814963020513 | DC-108 |
| 00814963020506 | DC-109 |
| 00814963020490 | DC-103 |