← Back to catalogue

Dimension® Cuvette Cartridge

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Dimension® Cuvette Cartridge FDA UDI
Generic Name
Laboratory analyser cuvette IVD, single-use FDA UDI
Device Name
Cuvette Cartridge - Dimension® - 1 Cartridge FDA UDI
Model / Reference
10445042 FDA UDI
Description
Cuvette Cartridge - Dimension® - 1 Cartridge FDA UDI

Identifiers

Catalog Number
D828 FDA UDI
Primary DI / UDI-DI
00842768014086 FDA UDI
FDA Product Code
JJE FDA UDI
GMDN Term
Laboratory analyser cuvette IVD, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2160 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Laboratory analyser cuvette IVD, single-use

Dimension® Cuvette Cartridge by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laboratory analyser cuvette IVD, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI ce1b3d6b-2c36-49e4-870d-5d80bc07b871 36 fields · synced May 29, 2026