AccessGUDID - DEVICE: Dimension Vista® System FPSA Flex® Reagent Cartridge (00842768016677)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension Vista® System FPSA Flex® Reagent Cartridge
Version or Model: 10445091
Commercial Distribution Status: In Commercial Distribution
Catalog Number: K6452
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768016677
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Free Prostate Specific Antigen Flex® reagent cartridge 80 Test

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:	Yes
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?
54669	Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of free (unbound) prostate specific antigen (fPSA) in any of the isoforms [i.e., benign PSA (BPSA), inactive/intact PSA, and/or the PSA precursor, proPSA] in a clinical specimen, using a chemiluminescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MTG	Test,Prostate Specific Antigen,Free,(Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P020027	009
P020027	013
P020027	015
P020027	020

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: 0510eb5a-af0e-490e-abf6-6f6e9d56d56e
Public Version Date: May 03, 2023
Public Version Number: 8
DI Record Publish Date: September 24, 2014