BluLink

GUDID MHC18490012

BluLink Meter Kit

MHC MEDICAL PRODUCTS, LLC

Glucose monitoring system IVD, home-use

• Primary Device ID: MHC18490012
• NIH Device Record Key: f7773289-71db-44df-af28-37e0f755eab3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BluLink
• Version Model Number: 849001
• Company DUNS: 169895245
• Company Name: MHC MEDICAL PRODUCTS, 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: 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
HIBCC	MHC18490012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201396

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: 2021-05-20
• Device Publish Date: 2021-05-12

On-Brand Devices [BluLink]

• MHC18490112: BluLink Test Strips 50ct
• MHC18490012: BluLink Meter Kit