Element™Plus Test Strips

Basic Information

• Brand Name: Element™Plus Test Strips
• Primary DI: 08809115908957
• Version / Model: IGM-0021B
• Company Name: OSANG HEALTHCARE Co., Ltd.
• Labeler DUNS: 688195374
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-21
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: ac0988cb-de2d-48c7-8f92-16a3aff8848a

Device Description

Blood Glucose Monitoring System

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	862.1345	2
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53303	Glucose IVD, kit, electrometry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	08809115908964	GS1		2	In Commercial Distribution
Primary	08809115908957	GS1
Secondary	8522-0000-64	NDC/NHRIC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K103021	000

Device Sizes

Type	Value	Unit	Text
Total Volume	0.3	Microliter

Storage Conditions

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