iSage Rx

GUDID 00850006610006

iSage Rx Insulin Titration Software

Amalgam Rx Inc

Pharmaceutical management support software, patient-/professional-use

• Primary Device ID: 00850006610006
• NIH Device Record Key: 8dbe6f6d-4d74-43a6-a6df-7ad08723185a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iSage Rx
• Version Model Number: Version 1.X
• Company DUNS: 080284502
• Company Name: Amalgam Rx 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: true
• Serial Number: false
• Manufacturing Date: true
• 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	00850006610006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161865

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: 2020-12-15
• Device Publish Date: 2020-12-07