PRISMASATE 114723

GUDID 37332414114764

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: 37332414114764
• NIH Device Record Key: d6f8916d-ea88-4c29-9c23-6c885eda3934
• Commercial Distribution Discontinuation: 2019-05-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: PRISMASATE
• Version Model Number: 114723
• Catalog Number: 114723
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)229-0001
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 0 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332414114763 [Primary]
GS1	37332414114764 [Package]; Contains: 07332414114763; Package: CASE [2 Units]; Discontinued: 2019-05-08; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120333

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: 5
• Public Version Date: 2019-05-14
• 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