AccessGUDID - DEVICE: Calibrator 2 (04580262010314)

GUDID

Device Identifier (DI) Information

Brand Name: Calibrator 2
Version or Model: 20-27-0478
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20-27-0478
Company Name: TOKYO BOEKI MEDISYS INC.

Primary DI Number: 04580262010314
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 696265656 *Terms of Use

Device Description: No description.

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?
52867	Multiple electrolyte IVD, calibrator	A material which is used to establish known points of reference for a number of assays intended to be used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIX	Calibrator, Multi-Analyte Mixture

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K040958	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 10 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ff2a7427-f863-4286-bdef-6ea2b0a7074b
Public Version Date: February 02, 2024
Public Version Number: 2
DI Record Publish Date: December 18, 2023