AccessGUDID - DEVICE: EasyElectrolyte Reagent Module, Na/K/Cl Analyzers (00386100002541)

GUDID

Device Identifier (DI) Information

Brand Name: EasyElectrolyte Reagent Module, Na/K/Cl Analyzers
Version or Model: 4102-0000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4102-0000
Company Name: MEDICA CORPORATION

Primary DI Number: 00386100002541
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 112942404 *Terms of Use

Device Description: EasyElectrolyte Reagent Module for Na/K/Cl Analyzers

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):	Yes
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
JGS	Electrode, Ion Specific, Sodium
CEM	Electrode, Ion Specific, Potassium
CGZ	Electrode, Ion-Specific, Chloride

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K000926	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 4 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3f02133e-0260-419b-ae47-ee25efdeb7aa
Public Version Date: January 11, 2019
Public Version Number: 1
DI Record Publish Date: December 11, 2018