Optiflux (UDI 0500318N)
Manufactured by Fresenius Medical Care Holdings, Inc.
Device Regulatory Overview
The Optiflux (Model/Catalog Number: 0500318N) is a medical device manufactured by Fresenius Medical Care Holdings, Inc.. This product is indexed under FDA Product Code / Category Classification KDI within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
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Technical Specifications
- Model Number
- 0500318N
- Product Code / EMDN
- KDI
- Device Name
- F180NR Optiflux Dialyzer / High Flux / Polysulfone / 1.7 m2 / ETO / Single Use / 97 mL
- Database Sync Date
- 2026-08-09 09:35:09
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 Optiflux?
The registered manufacturer of record for Optiflux is Fresenius Medical Care Holdings, Inc..
What is the Primary UDI-DI identifier for Optiflux?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 0500318N.
What classification code is assigned to this device?
This device is registered under product classification code KDI.
Similar Classification Devices (KDI)
Other Devices by Fresenius Medical Care Holdings, Inc.
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