AccessGUDID - DEVICE: Dimension Vista® / Dimension® EXL™ LCTNI CON M (00842768037528)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension Vista® / Dimension® EXL™ LCTNI CON M
Version or Model: 10707957
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: KC682
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768037528
Issuing Agency: GS1
Commercial Distribution End Date: July 06, 2022
Device Count: 12
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: LOCI Cardiac Troponin-I Control (medium), 12 vials x2.2mL

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 [?]
K121084	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: 471f7895-8432-4597-9429-a9d068a6d51e
Public Version Date: July 07, 2022
Public Version Number: 3
DI Record Publish Date: September 24, 2020