gudid
Primary ID: 113917
PrismaSATE (UDI 113917)
Manufactured by BAXTER INTERNATIONAL INC.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for PrismaSATE - Primary ID 113917
Device Regulatory Overview
The PrismaSATE (Model/Catalog Number: 113917) is a medical device manufactured by BAXTER INTERNATIONAL INC.. This product is indexed under FDA Product Code / Category Classification KPO within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 113917
- Product Code / EMDN
- KPO
- Device Name
- 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.
- Database Sync Date
- 2026-08-09 09:10:27
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of PrismaSATE?
The registered manufacturer of record for PrismaSATE is BAXTER INTERNATIONAL INC..
What is the Primary UDI-DI identifier for PrismaSATE?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 113917.
What classification code is assigned to this device?
This device is registered under product classification code KPO.
Similar Classification Devices (KPO)
Other Devices by BAXTER INTERNATIONAL INC.
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