ELERA

GUDID 16939184600359

Blood Glucose Test Strips

Bioland Technology Ltd.

Glucose monitoring system IVD, home-use

• Primary Device ID: 16939184600359
• NIH Device Record Key: 4791f8cd-1392-4e96-ad80-9d85569df1df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELERA
• Version Model Number: G-427BS
• Company DUNS: 545852548
• Company Name: Bioland Technology Ltd.
• Device Count: 1
• DM Exempt: true
• 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: false
• 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	06939184600352 [Primary]
GS1	16939184600359 [Package]; Contains: 06939184600352; Package: [20 Units]; In Commercial Distribution
GS1	26939184600356 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191657

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: 2023-08-23
• Device Publish Date: 2023-08-15

On-Brand Devices [ELERA]

• 16939184630479: Blood Glucose Monitoring System
• 16939184600359: Blood Glucose Test Strips