Bicarby
GUDID 10840861102911
Bicarby Dialysate RFP-404
Fresenius Medical Care Renal Therapies Group, LLC
Haemodialysis dialysate solution| Primary Device ID | 10840861102911 |
| NIH Device Record Key | ba30425e-bccc-4c04-8a52-6bb8ca083829 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bicarby |
| Version Model Number | RFP-404-G |
| Company DUNS | 079732391 |
| Company Name | Fresenius Medical Care Renal Therapies Group, 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Total Volume | 5000 Milliliter |
| Total Volume | 5000 Milliliter |
| Total Volume | 5000 Milliliter |
| Total Volume | 5000 Milliliter |
| Total Volume | 5000 Milliliter |
| Total Volume | 5000 Milliliter |
| Total Volume | 5000 Milliliter |
| Total Volume | 5000 Milliliter |
| Total Volume | 5000 Milliliter |
| Total Volume | 5000 Milliliter |
| Total Volume | 5000 Milliliter |
| Total Volume | 5000 Milliliter |
| Total Volume | 5000 Milliliter |
| Total Volume | 5000 Milliliter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840861102914 [Primary] |
| GS1 | 10840861102911 [Package] Contains: 00840861102914 Package: Case [2 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K243786
FDA Product Code
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-10 |
| Device Publish Date | 2025-06-02 |
On-Brand Devices [Bicarby]
| 10840861102850 | Bicarby Dialysate RFP-401 |
| 10840861102843 | Bicarby Dialysate RFP-407 |
| 00840861102839 | Bicarby Dialysate RFP-400 |
| 10840861102829 | Bicarby Dialysate RFP-402 |
| 10840861102942 | Bicarby Dialysate RFP-456 |
| 10840861102911 | Bicarby Dialysate RFP-404 |
Trademark Results [Bicarby]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BICARBY 98527562 not registered Live/Pending |
Fresenius Medical Care Holdings, Inc. 2024-04-30 |
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