EasyBloodGas Analyzer

Basic Information

• Brand Name: EasyBloodGas Analyzer
• Primary DI: 00386100002299
• Version / Model: 6001
• Catalog Number: 6001
• Company Name: MEDICA CORPORATION
• Labeler DUNS: 112942404
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-05
• Public Version: 2
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: be7ac9c9-74ca-47c1-83c7-191c991c5c57

Device Description

EasyBloodGas Analyzer

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: No
• Has Lot/Batch Number: Yes
• 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
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	862.1120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56661	Blood gas analyser IVD, laboratory	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the quantitative in vitro measurement of blood pH, partial pressure of oxygen (pO2) and/or partial pressure of carbon dioxide (pCO2), and the calculation of other blood gas parameters [e.g., bicarbonate (HCO3-), base excess, arterial-alveolar gradient] in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00386100002299	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K974526	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 25 Degrees Celsius