AccessGUDID - DEVICE: Dimension Vista® CTNI CAL (00842768016738)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension Vista® CTNI CAL
Version or Model: 10445197
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: KC678
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768016738
Issuing Agency: GS1
Commercial Distribution End Date: October 06, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Cardiac Troponin I Calibrator, 2x6x1mL

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?
54011	Troponin I IVD, calibrator	A material which is used to establish known points of reference for 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
JIT	CALIBRATOR, SECONDARY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K053577	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
Storage Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0577c705-b7a6-49dd-9ff2-a2642b3dc419
Public Version Date: October 07, 2022
Public Version Number: 6
DI Record Publish Date: September 24, 2016