AccessGUDID - DEVICE: IMMULITE®/IMMULITE®1000 Systems PSA PSA Sample Diluent (00630414954196)

GUDID

Device Identifier (DI) Information

Brand Name: IMMULITE®/IMMULITE®1000 Systems PSA PSA Sample Diluent
Version or Model: 10386994
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LPSZ
Company Name: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Primary DI Number: 00630414954196
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 296822794 *Terms of Use

Device Description: PSA Sample Diluent

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?
58237	Buffered sample diluent IVD	A buffered diluent solution intended to be used as a consumable reagent during manual procedures or on-board an automated or semi-automated instrument (e.g., haematological cell analyser) for the processing, staining and/or testing of clinical laboratory specimens (e.g., whole blood).	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 [?]
P930027	001
P930027	004
P930027	005

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
Special Storage Condition, Specify: Protect from Light
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: 9f7c1fcd-ecdf-44ac-8499-45b8a0335191
Public Version Date: June 13, 2023
Public Version Number: 6
DI Record Publish Date: September 24, 2014