PRISMASATE 106957C
GUDID 50085412645822
The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal failure) using Continuous Renal Replacement Therapies, such as continuous hemodialysis and hemodiafiltration aimed at normalizing the composition of the blood. The product may also be used in case of drug poisoning with dialyzable or filterable substances.
BAXTER HEALTHCARE CORPORATION
Haemodialysis concentrate| Primary Device ID | 50085412645822 |
| NIH Device Record Key | 066ad1d1-63c2-4c9e-bac9-e337b23557f9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PRISMASATE |
| Version Model Number | 106957 |
| Catalog Number | 106957C |
| Company DUNS | 005083209 |
| Company Name | BAXTER HEALTHCARE CORPORATION |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00085412645827 [Primary] |
| GS1 | 50085412645822 [Package] Contains: 00085412645827 Package: CASE [2 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K072908
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 | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-11-04 |
| Device Publish Date | 2018-12-21 |
Devices Manufactured by BAXTER HEALTHCARE CORPORATION
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Trademark Results [PRISMASATE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRISMASATE 78032988 2670296 Live/Registered |
GAMBRO RENAL PRODUCTS, INC. 2000-10-30 |
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