EPOC HOST, RX, CA

Basic Information

• Brand Name: EPOC HOST, RX, CA
• Primary DI: 00809708064044
• Version / Model: HH-0005-CA-00
• Catalog Number: HH-0005-CA-00
• Company Name: Epocal Inc
• Labeler DUNS: 201179681
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-05
• Public Version: 6
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: 15c1b624-8759-44dc-9b28-e50c2eaa999f

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	862.1600	2
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	862.1345	2
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	862.1170	2
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	862.1120	2
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	862.1145	2
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	862.1665	2
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	862.1450	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56667	Metabolic profile clinical chemistry analyser IVD	A portable, electrically-powered automated or semi-automated 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., pO2, 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)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00809708064044	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]