CitraPure D5-112
GUDID 00814963021084
ROCKWELL MEDICAL, INC.
Haemodialysis concentrate| Primary Device ID | 00814963021084 |
| NIH Device Record Key | 0d346059-f764-4e15-88c7-1f9751b969c6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CitraPure |
| Version Model Number | D5-112 |
| Catalog Number | D5-112 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814963021084 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K062399
FDA Product Code
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-09-18 |
On-Brand Devices [CitraPure]
Trademark Results [CitraPure]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CITRAPURE 97106110 not registered Live/Pending |
Kerry Luxembourg S.Ã .r.l. 2021-11-03 |
 CITRAPURE 78885375 3851758 Live/Registered |
ROCKWELL MEDICAL, INC. 2006-05-17 |
 CITRAPURE 77058863 3701950 Live/Registered |
KERRY LUXEMBOURG S.Ã.R.L. 2006-12-07 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.