Genteel BT100 BT-100T

GUDID 00860013530211

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

LIGHT HILL MEDICAL CORPORATION

Glucose IVD, kit, electrometry

• Primary Device ID: 00860013530211
• NIH Device Record Key: bd441a5d-e509-42f3-9876-fbf2e4a733f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genteel BT100
• Version Model Number: BT-100T
• Catalog Number: BT-100T
• Company DUNS: 133895468
• Company Name: LIGHT HILL MEDICAL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860013530211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182046

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-15
• Device Publish Date: 2025-04-07

On-Brand Devices [Genteel BT100]

• 00860013530211: Genteel Test Strips for the Genteel BT100-M Blood Glucose Meter. Pack of 50.
• 00860013530204: Genteel Blood Glucose Meter