AccessGUDID - DEVICE: Dimension Vista® LOCI 1 CAL (00842768016714)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension Vista® LOCI 1 CAL
Version or Model: 10445194
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KC660
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768016714
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: LOCI 1 Calibrator, 2x4x1.5mL / 2x2x2mL

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?
61253	Multiple thyroid marker IVD, calibrator	A material which is used to establish known points of reference for a number of assays intended to be used for the qualitative and/or quantitative detection of multiple thyroid markers associated with thyroid disease in a clinical specimen. Analytes detected may include, but are not limited to free triiodothyronine (FT3), free thyroxine (FT4), thyroid stimulating hormone (TSH) and/or thyroid peroxidase (TPO).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIT	CALIBRATOR, SECONDARY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K053531	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 -70 and -20 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dcde535e-bcf7-4454-a6dc-2e14ae5bfd8d
Public Version Date: May 04, 2023
Public Version Number: 6
DI Record Publish Date: September 24, 2016