Oh'Care Lite Smart Glucose control solution-Level 1

Basic Information

• Brand Name: Oh'Care Lite Smart Glucose control solution-Level 1
• Primary DI: 08809115906519
• Version / Model: IGM-1003F
• Company Name: OSANG HEALTHCARE Co., Ltd.
• Labeler DUNS: 688195374
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-17
• Public Version: 1
• Public Version Date: 2019-09-25
• Public Version Status: New
• Public Device Record Key: 1a36cdb5-ffae-4c9a-90f8-9b87f09ab8ed

Device Description

blood glucose meter and test strip control solution level 1

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: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41819	Glucose IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809115906519	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K182286	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 46 – 86 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 8 – 30 Degrees Celsius