GlucoLeader Enhance Blood Glucose Monitoring System 3K-01-140039

GUDID 04711200720570

GlucoLeader Enhance GEBH Blood Glucose Monitoring System.

HMD BIOMEDICAL INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 04711200720570
• NIH Device Record Key: ebaf7752-4c7d-4f19-b620-94246395ca87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GlucoLeader Enhance Blood Glucose Monitoring System
• Version Model Number: 3K-01-140039
• Catalog Number: 3K-01-140039
• Company DUNS: 658644174
• Company Name: HMD BIOMEDICAL INC.
• 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: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	04711200720570 [Primary]
GS1	04711200723014 [Package]; Package: KIT [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032985

FDA Product Code

• CGA: Glucose Oxidase, Glucose

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: 2021-01-13
• Device Publish Date: 2021-01-05

On-Brand Devices [GlucoLeader Enhance Blood Glucose Monitoring System]

• 04711200720617: GlucoLeader Enhance GEBH Blood Glucose Monitoring System
• 04711200720570: GlucoLeader Enhance GEBH Blood Glucose Monitoring System.