AccessGUDID - DEVICE: ADVIA Centaur Cortisol Urine Reconstitution Buffer (00630414121819)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA Centaur Cortisol Urine Reconstitution Buffer
Version or Model: 10318246
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 570408
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414121819
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Cortisol Urin - CENTAUR - CTL - 1x50mL

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?
54128	Total cortisol IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of total cortisol in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JFT	FLUOROMETRIC, CORTISOL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K962559	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
Special Storage Condition, Specify: store upright
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: f661092f-9d44-4ec9-816a-cbdaa9ac9cdb
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016