AccessGUDID - DEVICE: DImension Vista® Prealbumin Flex® reagent cartridge (00842768006210)

GUDID

Device Identifier (DI) Information

Brand Name: DImension Vista® Prealbumin Flex® reagent cartridge
Version or Model: 10445906
Commercial Distribution Status: In Commercial Distribution
Catalog Number: K7064
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00842768006210
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 Prealbumin in human serum and plasma 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?
53657	Collagen pyridium crosslink IVD, reagent	A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of the pyridium crosslinks of collagen, deoxypyridinoline (DPD) and/or pyridinoline (PYD), in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JZJ	PREALBUMIN, ANTIGEN, ANTISERUM, CONTROL

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: c3d53c8f-72ea-46c1-b9ef-ec93d566b1be
Public Version Date: March 22, 2022
Public Version Number: 3
DI Record Publish Date: September 24, 2020