Digistat Smart Central

GUDID 17350097870032

Digistat Smart Central is an on-site integration solution which forwards medical device status and alarm information to the user via display devices p

ASCOM UMS SRL

Alarm application software Alarm application software

• Primary Device ID: 17350097870032
• NIH Device Record Key: d58b40f0-ad0e-4ddd-9be5-86a73d6ee9da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Digistat Smart Central
• Version Model Number: SW000754
• Company DUNS: 429174886
• Company Name: ASCOM UMS SRL
• 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	17350097870032 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180430

FDA Product Code

• PHC: Infusion Safety Management Software

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: 2019-03-25
• Device Publish Date: 2019-03-15