AccessGUDID - DEVICE: Dimension Vista® System TPSA Flex® Reagent Cartridge (00842768016660)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension Vista® System TPSA Flex® Reagent Cartridge
Version or Model: 10445090
Commercial Distribution Status: In Commercial Distribution
Catalog Number: K6451
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768016660
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Total Prostate Specific Antigen Flex® reagent cartridge 120 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?
54665	Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total prostate specific antigen (tPSA) in a clinical specimen, using a chemiluminescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MTF	Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P000021	013
P000021	018
P000021	020
P000021	039

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: 9e403e58-69cb-4115-a86b-fe9561bafbae
Public Version Date: November 18, 2021
Public Version Number: 7
DI Record Publish Date: September 24, 2014