gudid Primary ID: 0198-00-0087

COVER,CARDIOSAVE RAIN (UDI 0198-00-0087)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The COVER,CARDIOSAVE RAIN (Model/Catalog Number: 0198-00-0087) 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: 0198-00-0087
Product Code / EMDN: DSP
Device Name: COVER,CARDIOSAVE RAIN
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 COVER,CARDIOSAVE RAIN?

The registered manufacturer of record for COVER,CARDIOSAVE RAIN is Datascope Corp..

What is the Primary UDI-DI identifier for COVER,CARDIOSAVE RAIN?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 0198-00-0087.

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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