Dimension® Flex® reagent cartridge BUN

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: Dimension® Flex® reagent cartridge BUN FDA UDI
Generic Name: Urea IVD, kit, enzyme spectrophotometry FDA UDI
Device Name: Urea Nitrogen Flex® reagent cartridge, 480 tests FDA UDI
Model / Reference: 10444969 FDA UDI
Description: Urea Nitrogen Flex® reagent cartridge, 480 tests FDA UDI

Identifiers

Catalog Number: DF21 FDA UDI
Primary DI / UDI-DI: 00842768014116 FDA UDI
FDA Product Code: CDQ FDA UDI
JJE FDA UDI
GMDN Term: Urea IVD, kit, enzyme spectrophotometry FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1770 FDA UDI
862.2160 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Urea IVD, kit, enzyme spectrophotometry

Dimension® Flex® reagent cartridge BUN by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Siemens Healthcare Diagnostics

Sources (1)

FDA UDI eb402e5a-07ed-4de0-b76a-8d8cc1ee1224 36 fields · synced May 30, 2026