HealthPro

GUDID MHC18090112

Healthpro Control Solution

MHC MEDICAL PRODUCTS, LLC

Glucose monitoring system IVD, home-use

• Primary Device ID: MHC18090112
• NIH Device Record Key: 105fd3df-a207-4cce-994c-ec8fc4945093
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HealthPro
• Version Model Number: 809011
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	MHC18090112 [Primary]

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-04-27
• Device Publish Date: 2016-08-01

Devices Manufactured by MHC MEDICAL PRODUCTS, LLC

• MHC18090112 - HealthPro: 2023-04-27Healthpro Control Solution
• MHC18090112 - HealthPro: 2023-04-27 Healthpro Control Solution
• MHC18020241 - EasyTouch: 2022-05-12 ET 20mL Luer Lock Barrel Only (TB)
• MHC18020641 - EasyTouch: 2022-05-12 ET 60mL Luer Lock Barrel Only (TB)
• MHC18070022 - EasyTouch: 2022-05-12 ET Glucose Meter Only
• MHC18152001 - EasyTouch: 2022-05-12 ET 25G 5/8 in Fluringe (FlipLock Needle Only)
• MHC18152011 - EasyTouch: 2022-05-12 ET 25G 1 in Fluringe (FlipLock Needle Only)
• MHC18223211 - EasyTouch: 2022-05-12 ET 23G 1 in 1mL Low Dead Space FlipLock Syr
• MHC18223611 - EasyTouch: 2022-05-12 ET 23G 1 in 3mL Low Dead Space FlipLock Syr