CURO L5 Meter

Basic Information

• Brand Name: CURO L5 Meter
• Primary DI: 08809115905406
• Version / Model: ILM-0001A
• Company Name: OSANG HEALTHCARE Co., Ltd.
• Labeler DUNS: 688195374
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-09
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 10108fe6-cf96-4b9c-9d00-e5fea66e35b9

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: 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
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	862.1175	1
JGY	Colorimetric Method, Triglycerides	Clinical Chemistry	862.1705	1

GMDN Terms

Code	Name	Definition	Implantable	Status
30222	Total cholesterol lipid IVD, kit, chemiluminescent immunoassay, rapid	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of total cholesterol lipid in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a chemiluminescent immunoassay method. This test is commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809115905406	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K130295	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 36 – 86 Degrees Fahrenheit