Renpho Blood Glucose Monitoring System

GUDID 04711200722901

Renpho Blood Glucose Monitoring System

HMD BIOMEDICAL INC.

Glucose IVD, kit, electrometry

• Primary Device ID: 04711200722901
• NIH Device Record Key: e566f7c2-183f-43ff-8d36-7e6c0173102c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renpho Blood Glucose Monitoring System
• Version Model Number: 3K-01-1400A2
• 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04711200722888 [Primary]
GS1	04711200722901 [Package]; Contains: 04711200722888; Package: BOX [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121433

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: 2020-10-29
• Device Publish Date: 2020-10-21

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