PrismaSATE 113915
GUDID 37332414108589
The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal failure) using Continuous Renal Replacement Therapies
BAXTER INTERNATIONAL INC.
Haemodialysis concentrate| Primary Device ID | 37332414108589 |
| NIH Device Record Key | 14e48ddb-7729-4679-946e-3ea644966504 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PrismaSATE |
| Version Model Number | 113915 |
| Catalog Number | 113915 |
| 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 39 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 0 Degrees Celsius |
| 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 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 | 07332414108588 [Primary] |
| GS1 | 37332414108589 [Package] Contains: 07332414108588 Package: CASE [2 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K013448
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 | 3 |
| Public Version Date | 2018-07-06 |
| 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 |
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