gudid Primary ID: 15043-000-0005

Splitter- US (UDI 15043-000-0005)

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Splitter- US (Model/Catalog Number: 15043-000-0005) is a medical device manufactured by EITAN MEDICAL LTD. This product is indexed under FDA Product Code / Category Classification MRZ within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 1 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-0094-2024 View Full Alert →

Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)...

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Technical Specifications

Model Number: 15043-000-0005
Product Code / EMDN: MRZ
Device Name
Database Sync Date: 2026-08-09 09:21:56

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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Frequently Asked Questions

Who is the primary manufacturer of Splitter- US?

The registered manufacturer of record for Splitter- US is EITAN MEDICAL LTD.

What is the Primary UDI-DI identifier for Splitter- US?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 15043-000-0005.

What classification code is assigned to this device?

This device is registered under product classification code MRZ.

Similar Classification Devices (MRZ)

Other Devices by EITAN MEDICAL LTD

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