Bi-Level QC Kit, HCT

Basic Information

• Brand Name: Bi-Level QC Kit, HCT
• Primary DI: 00386100002633
• Version / Model: 7309
• Catalog Number: 7309
• 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: 1
• Public Version Date: 2019-01-07
• Public Version Status: New
• Public Device Record Key: a4d17e01-7de7-4a7a-98e8-dc460216508c

Device Description

Bi-Level QC Kit, HCT

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
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	862.1145	2
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	862.1600	2
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	862.1665	2
GKF	Instrument, Hematocrit, Automated	Hematology	864.5600	2
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	862.1120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52860	Multiple blood gas/haemoximetry/electrolyte analyte IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00386100002633	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K021515	000

Storage Conditions

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