GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM

GUDID 00713757465007

GENESIS HEALTH TECHNOLOGIES, LLC

Glucose monitoring system IVD, home-use

• Primary Device ID: 00713757465007
• NIH Device Record Key: 00bafd84-308f-48e2-97fb-13219ccb0a4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM
• Version Model Number: TD-4123
• Company DUNS: 961576258
• Company Name: GENESIS HEALTH TECHNOLOGIES, LLC
• 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: true
• 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	00713757465007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121224

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: 2020-01-31
• Device Publish Date: 2020-01-23

Devices Manufactured by GENESIS HEALTH TECHNOLOGIES, LLC

• 00713757465007 - GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM: 2020-01-31
• 00713757465007 - GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM: 2020-01-31
• 00713757464802 - GHT Test Strip: 2018-03-29