AccessGUDID - DEVICE: ADVIA Centaur® TnI-Ultra MCM (00630414515892)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA Centaur® TnI-Ultra MCM
Version or Model: 10317626
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2738323
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414515892
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Troponin I Ultra Master Curve Material Set - CENTAUR - CONS

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?
54012	Troponin I IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of troponin I in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJX	SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140267	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: 5818a371-fd7f-440b-add9-701fe0a5a050
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016