Blood Gas and Chemistry Analyzer

Basic Information

• Brand Name: Blood Gas and Chemistry Analyzer
• Primary DI: 06944413801875
• Version / Model: i15
• Company Name: Edan Instruments, Inc.
• Labeler DUNS: 529173163
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 7299c48f-9aa8-4587-ba41-ba56822db901

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GLK	Control, Hematocrit	Hematology	864.8625	2
JJS	Controls For Blood-Gases, (Assayed And Unassayed)	Clinical Chemistry	862.1660	1
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	862.1150	2
GKF	Instrument, Hematocrit, Automated	Hematology	864.5600	2
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	862.1145	2
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	862.1170	2
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	862.1600	2
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	862.1665	2
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	862.1120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56670	Metabolic profile clinical chemistry analyser IVD, stationary, semi-automated	A stationary mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro measurement of multiple clinical chemistry analytes to generate a metabolic profile. Analytes may include pH, blood gas parameters [e.g., partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2)], electrolytes [e.g., sodium (Na2+), potassium (K+), chloride (Cl-)], glucose, urea, creatinine and sometimes in addition haemoximetry parameters [e.g., carboxy-haemoglobin (COHb), methaemoglobin (MetHb), total haemoglobin (totHb), hematrocrit (Hct)]. It operates with reduced technician involvement and automation of some, not all, procedural steps.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06944413801875	GS1

Premarket Submissions

Submission Number	Supplement Number
K151978	000