GUDIDData
Bulk Audit Tool API Access
enforcement Primary ID: Z-1980-2026

Dimension Creatinine Flex reagent cartridge. Material Number: 10872079. (UDI Z-1980-2026)

Manufactured by Siemens Healthcare Diagnostics, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Dimension Creatinine Flex reagent cartridge. Material Number: 10872079. - Primary ID Z-1980-2026

Device Regulatory Overview

The Dimension Creatinine Flex reagent cartridge. Material Number: 10872079. (Model/Catalog Number: Unspecified) is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. This product is indexed under FDA Product Code / Category Classification Material Number: 10872079. Model Number: DF33B. UDI: (01)00630414595009(10)GA6307(17)20261103, (01)00630414595009(10)BA7005(17)20270105. Lot Numbers: GA6307, BA7005. 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-2753-2026 View Full Alert →

FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-2755-2026 View Full Alert →

FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, I...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-2793-2026 View Full Alert →

SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System...

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

Technical Specifications

Model Number
N/A
Device Name
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
Database Sync Date
2026-08-09 10:06:32

Full Regulatory Attributes

🔒 Token Gated 
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

Unlock Compliance Data & Serialization Specs

Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

Get API Token Access ($49/mo)

Frequently Asked Questions

Who is the primary manufacturer of Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.?

The registered manufacturer of record for Dimension Creatinine Flex reagent cartridge. Material Number: 10872079. is Siemens Healthcare Diagnostics, Inc..

What is the Primary UDI-DI identifier for Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-1980-2026.

What classification code is assigned to this device?

This device is registered under product classification code Material Number: 10872079. Model Number: DF33B. UDI: (01)00630414595009(10)GA6307(17)20261103, (01)00630414595009(10)BA7005(17)20270105. Lot Numbers: GA6307, BA7005..

Other Devices by Siemens Healthcare Diagnostics, Inc.

Programmatic Export

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

JSON API Endpoint