AccessGUDID - DEVICE: Dimension® Cuvette Cartridge (00842768014086)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension® Cuvette Cartridge
Version or Model: 10445042
Commercial Distribution Status: In Commercial Distribution
Catalog Number: D828
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768014086
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Cuvette Cartridge - Dimension® - 1 Cartridge

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61032	Laboratory analyser cuvette IVD, single-use	A small volume, rectangular column designed to contain a clinical specimen, reagent, or other material for in vitro diagnostic testing procedures performed by a laboratory analyser. It is transparent to allow light to travel through the contained material and is typically made of plastic, glass or quartz with a flat base and an open top. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJE	ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ce1b3d6b-2c36-49e4-870d-5d80bc07b871
Public Version Date: November 18, 2021
Public Version Number: 3
DI Record Publish Date: September 24, 2020