SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+

GUDID 00811403010028

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.

Diamond Diagnostics Inc.

Ion-selective analyser IVD

• Primary Device ID: 00811403010028
• NIH Device Record Key: 59e64393-97ea-4ed0-b9ac-deb21aeec548
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+
• Version Model Number: 0-DD-SMARTLYTEPLUS
• Company DUNS: 947514303
• Company Name: Diamond Diagnostics Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811403010028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200544

FDA Product Code

• JJE: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-13
• Device Publish Date: 2023-06-05

Devices Manufactured by Diamond Diagnostics Inc.

• 00811403010158 - Photometer Lamp: 2023-06-21
• 00811403010240 - Reference Solution: 2023-06-21
• 00811403013074 - Pump Tubing Kit: 2023-06-21
• 00811403013173 - C1/C2 Cleaning Solution: 2023-06-21
• 00811403010387 - Wash Pack: 2023-06-21
• 00811403013296 - pH Electrode: 2023-06-21
• 00811403013302 - Calcium Electrode: 2023-06-21
• 00811403013319 - Potassium Electrode: 2023-06-21