AccessGUDID - DEVICE: DImension Vista® Microalbumin Flex® reagent cartridge (00842768006203)

GUDID

Device Identifier (DI) Information

Brand Name: DImension Vista® Microalbumin Flex® reagent cartridge
Version or Model: 10445905
Commercial Distribution Status: In Commercial Distribution
Catalog Number: K7062
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00842768006203
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 388240673 *Terms of Use

Device Description: For the quantitative measurement of albumin in human urine on the Dimension Vista® System

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?
53596	Albumin IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of albumin in a clinical specimen, using a nephelometry/turbidimetry method. It is typically used to aid in the diagnosis and monitoring of diseases affecting protein metabolism (e.g., liver disease, kidney disease, severe malnutrition, malabsorption, burns).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DCF	ALBUMIN, ANTIGEN, ANTISERUM, CONTROL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K061990	000

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 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8c94344f-ede8-4f9c-8917-ffc1561ac83e
Public Version Date: August 18, 2025
Public Version Number: 7
DI Record Publish Date: September 24, 2016