GUDIDData
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gudid Primary ID: 0012-00-1589-04

CABLE,LOW LEVEL OUTPUT,GE (UDI 0012-00-1589-04)

Manufactured by Datascope Corp.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for CABLE,LOW LEVEL OUTPUT,GE - Primary ID 0012-00-1589-04

Device Regulatory Overview

The CABLE,LOW LEVEL OUTPUT,GE (Model/Catalog Number: 0012-00-1589-04) 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
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-1487-2026 View Full Alert →

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

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-0931-2026 View Full Alert →

Cardiosave Hybrid...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)

Technical Specifications

Model Number
0012-00-1589-04
Product Code / EMDN
DSP
Device Name
Database Sync Date
2026-08-09 09:31:01

Full Regulatory Attributes

🔒 Token Gated 
{
    "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 CABLE,LOW LEVEL OUTPUT,GE?

The registered manufacturer of record for CABLE,LOW LEVEL OUTPUT,GE is Datascope Corp..

What is the Primary UDI-DI identifier for CABLE,LOW LEVEL OUTPUT,GE?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 0012-00-1589-04.

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.

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

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