Glucommander

GUDID 00860057000305

GLYTEC, LLC

Infusion pump medication-dosage application software

• Primary Device ID: 00860057000305
• NIH Device Record Key: 3b6f0e15-6100-41db-86cf-4ec91860d29a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Glucommander
• Version Model Number: None
• Company DUNS: 069473272
• Company Name: GLYTEC, 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860057000305 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113853

FDA Product Code

• NDC: Calculator, Drug Dose

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-22
• Device Publish Date: 2016-09-21