Scan

Basic Information

• Brand Name: Scan
• Primary DI: 00860005561704
• Version / Model: G-427BS
• Company Name: LEXINGTON WELLNESS HOLDINGS INC.
• Labeler DUNS: 079437338
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-01
• Public Version: 1
• Public Version Date: 2021-02-09
• Public Version Status: New
• Public Device Record Key: ba412fe9-eb36-4aff-aae3-de0fbd2de6b5

Device Description

Blood glucose meter test strips.

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: No
• 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
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53307	Glucose IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is 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	00860005561704	GS1
Package	20860005561708	GS1	Inner Pack	100	In Commercial Distribution
Package	30860005561705	GS1	Case	2	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K191657	000