gudid
Primary ID: 106696MDR
PRISMAFLEX SET M60 (UDI 106696MDR)
Manufactured by Vantive Health GmbH
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for PRISMAFLEX SET M60 - Primary ID 106696MDR
Device Regulatory Overview
The PRISMAFLEX SET M60 (Model/Catalog Number: 106696MDR) is a medical device manufactured by Vantive Health GmbH. This product is indexed under FDA Product Code / Category Classification KDI within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 106696MDR
- Product Code / EMDN
- KDI
- Device Name
- The Prismaflex M60 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered) in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both.
- Database Sync Date
- 2026-08-09 09:10:27
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of PRISMAFLEX SET M60?
The registered manufacturer of record for PRISMAFLEX SET M60 is Vantive Health GmbH.
What is the Primary UDI-DI identifier for PRISMAFLEX SET M60?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 106696MDR.
What classification code is assigned to this device?
This device is registered under product classification code KDI.
Similar Classification Devices (KDI)
Other Devices by Vantive Health GmbH
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint