GlucoCare

GUDID G111GCR2

GlucoCare Intensive Glycemic Control System

Pronia Medical Systems Inc.

Clinical management support software

• Primary Device ID: G111GCR2
• NIH Device Record Key: de89cbaa-40a9-4365-8dfe-8fb169e5420c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GlucoCare
• Version Model Number: 2.X
• Company DUNS: 114808278
• Company Name: Pronia Medical Systems 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	G111GCR2 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081388

FDA Product Code

• NDC: Calculator, Drug Dose

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: 2022-08-10
• Device Publish Date: 2022-08-02