GUDIDData
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eudamed_udi Primary ID: 15099590750947

Access BNP (Reagent Pack) (UDI 15099590750947)

Manufactured by Beckman Coulter Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Access BNP (Reagent Pack) - Primary ID 15099590750947

Device Regulatory Overview

The Access BNP (Reagent Pack) (Model/Catalog Number: 98200) is a medical device manufactured by Beckman Coulter Inc.. This product is indexed under FDA Product Code / Category Classification W01021301 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-0071-2026 View Full Alert →

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🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-0441-2026 View Full Alert →

SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-0032-2026 View Full Alert →

DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clin...

🔒 Compromised Lot & Serial Numbers Locked
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Unlock Lot Data ($49)

Technical Specifications

Model Number
98200
Product Code / EMDN
W01021301
Device Name
Access BNP (Reagent Pack)
Database Sync Date
2026-08-09 16:29:01

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 Access BNP (Reagent Pack)?

The registered manufacturer of record for Access BNP (Reagent Pack) is Beckman Coulter Inc..

What is the Primary UDI-DI identifier for Access BNP (Reagent Pack)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 15099590750947.

What classification code is assigned to this device?

This device is registered under product classification code W01021301.

Similar Classification Devices (W01021301)

Other Devices by Beckman Coulter Inc.

Programmatic Export

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

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