GlucoLeader Enhance Blood Glucose Test Strip 3S-01-22X034

GUDID 04711200720068

GlucoLeader Enhance GL Blood Glucose Test Strip

HMD BIOMEDICAL INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 04711200720068
• NIH Device Record Key: 4c43592b-a91f-4f83-8218-642ec1af8d96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GlucoLeader Enhance Blood Glucose Test Strip
• Version Model Number: 3S-01-22X034
• Catalog Number: 3S-01-22X034
• 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: false
• 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	04711200720068 [Primary]
GS1	04711200723045 [Package]; Package: [200 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 Test Strip]

• 04711200722864: GlucoLeader Enhance GL Blood Glucose Test Strip
• 04711200720068: GlucoLeader Enhance GL Blood Glucose Test Strip