PrismaSATE 113917
GUDID 37332414108602
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 INTERNATIONAL INC.
Haemodialysis concentrate| Primary Device ID | 37332414108602 |
| NIH Device Record Key | 6688b4cb-a9f6-4ab8-a84b-90b8d0b9d1dc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PrismaSATE |
| Version Model Number | 113917 |
| Catalog Number | 113917 |
| Company DUNS | 005146311 |
| Company Name | BAXTER INTERNATIONAL 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 4 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 4 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 4 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 4 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 4 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 4 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 4 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 4 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 4 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 4 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 4 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 4 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 4 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 4 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 4 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 4 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 4 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 4 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 4 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 4 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 4 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 4 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 4 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 4 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 4 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 4 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332414108601 [Primary] |
| GS1 | 37332414108602 [Package] Contains: 07332414108601 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 | 4 |
| Public Version Date | 2019-11-04 |
| Device Publish Date | 2015-09-24 |
On-Brand Devices [PrismaSATE]
| 37332414123094 | The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal |
| 37332414114788 | The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal |
| 37332414114771 | The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal |
| 37332414114764 | The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal |
| 37332414108626 | The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal |
| 37332414108619 | The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal |
| 37332414108602 | The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal |
| 37332414108596 | The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal |
| 37332414108589 | The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal |
| 37332414108572 | The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal |
| 37332414100170 | The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal |
| 37332414074648 | The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal |
| 37332414074013 | The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal |
| 37332414066834 | The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal |
| 37332414037049 | The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal |
| 37332414037032 | The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal |
Trademark Results [PrismaSATE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRISMASATE 78032988 2670296 Live/Registered |
GAMBRO RENAL PRODUCTS, INC. 2000-10-30 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.