AccessGUDID - DEVICE: SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ (00811403010028)

GUDID

Device Identifier (DI) Information

Brand Name: SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+
Version or Model: 0-DD-SMARTLYTEPLUS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Diamond Diagnostics Inc.

Primary DI Number: 00811403010028
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 947514303 *Terms of Use

Device Description: The SmartLyte® Plus Na+, K+, Cl-, Ca++, Li+ Electrolyte Analyzer is a microprocessor-controlled analyzers which utilize ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in serum, plasma, whole blood, pre-diluted urine samples, and QC materials. The analyzer self-calibrates using Diamond Diagnostics Fluid Pack every 4 hours throughout the day or on request. Sodium, potassium, chloride and calcium are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Lithium is a drug used to treat mental illness.

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?
56682	Ion-selective analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the quantitative measurement of electrolytes and/or other ions in a clinical specimen using ion-specific membranes to selectively measure electrical potential against a reference electrode to determine the target ion concentration.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
CEM	Electrode, Ion Specific, Potassium
JGS	Electrode, Ion Specific, Sodium
CGZ	Electrode, Ion-Specific, Chloride
JFP	Electrode, Ion Specific, Calcium
JIH	Flame Photometry, Lithium

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 59e64393-97ea-4ed0-b9ac-deb21aeec548
Public Version Date: March 25, 2024
Public Version Number: 2
DI Record Publish Date: June 05, 2023