Dimension® Flex® reagent cartridge GLUC

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: Dimension® Flex® reagent cartridge GLUC FDA UDI
Generic Name: Glucose IVD, kit, spectrophotometry FDA UDI
Device Name: Glucose Flex® reagent cartridge, 1440 tests FDA UDI
Model / Reference: 10444971 FDA UDI
Description: Glucose Flex® reagent cartridge, 1440 tests FDA UDI

Identifiers

Catalog Number: DF40 FDA UDI
Primary DI / UDI-DI: 00842768005541 FDA UDI
510(k) Number: K112999 FDA UDI
FDA Product Code: CFR FDA UDI
GMDN Term: Glucose IVD, kit, spectrophotometry FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1345 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: Glucose IVD, kit, spectrophotometry

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

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Also classified as Glucose IVD, kit, spectrophotometry.

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ARCHITECT — Abbott Laboratories, Inc. · Class II
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Cleared under the same submission

K112999 also covers:

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 5a5ac118-f21c-4472-bb74-dbff18bdf067 37 fields · synced May 30, 2026