gudid Primary ID: 0998-00-0800-65

CARDIOSAVE HYBRID, 3.1 EDITION (UDI 0998-00-0800-65)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The CARDIOSAVE HYBRID, 3.1 EDITION (Model/Catalog Number: 0998-00-0800-65) is a medical device manufactured by Datascope Corp.. This product is indexed under FDA Product Code / Category Classification DSP within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-1486-2026 View Full Alert →

CS100 IABP. Software Version CS100 IABP Q.01....

🔒 Compromised Lot & Serial Numbers Locked

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ID: Z-1487-2026 View Full Alert →

CS300 IABP. Software Version CS300 IABP C.01....

🔒 Compromised Lot & Serial Numbers Locked

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ID: Z-0931-2026 View Full Alert →

Cardiosave Hybrid...

🔒 Compromised Lot & Serial Numbers Locked

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Technical Specifications

Model Number: 0998-00-0800-65
Product Code / EMDN: DSP
Device Name: CARDIOSAVE HYBRID, 3.1 EDITION
Database Sync Date: 2026-08-09 09:31:01

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 CARDIOSAVE HYBRID, 3.1 EDITION?

The registered manufacturer of record for CARDIOSAVE HYBRID, 3.1 EDITION is Datascope Corp..

What is the Primary UDI-DI identifier for CARDIOSAVE HYBRID, 3.1 EDITION?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 0998-00-0800-65.

What classification code is assigned to this device?

This device is registered under product classification code DSP.

Similar Classification Devices (DSP)

Other Devices by Datascope Corp.

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