Genteel BT100

Basic Information

• Brand Name: Genteel BT100
• Primary DI: 00860013530211
• Version / Model: BT-100T
• Catalog Number: BT-100T
• Company Name: LIGHT HILL MEDICAL CORPORATION
• Labeler DUNS: 133895468
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-07
• Public Version: 2
• Public Version Date: 2026-04-13
• Public Version Status: Update
• Public Device Record Key: bd441a5d-e509-42f3-9876-fbf2e4a733f1

Device Description

Genteel Test Strips for the Genteel BT100-M Blood Glucose Meter. Pack of 50.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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

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. It is typically in a strip format (e.g., screen-printed electrode) for use with a dedicated testing device (not included).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860013530211	GS1

Premarket Submissions

Submission Number	Supplement Number
K182046	000