Digistat Smart Central

FDA UDI

Class II (US FDA UDI)

by Ascom Ums Srl

Identity

Trade Name: Digistat Smart Central FDA UDI
Generic Name: Alarm application software FDA UDI
Device Name: Digistat Smart Central is an on-site integration solution which forwards medical device status and alarm information to the user via display devices provided by Ascom or third-party companies. Users receive, time-critical information from connected medical devices directly via their display devices as text, alarms or data. Digistat Smart Central allows users to be aware of their patients’ status and alarm conditions when they are away from the patient and associated medical devices. FDA UDI
Model / Reference: SW000754 FDA UDI
Description: Digistat Smart Central is an on-site integration solution which forwards medical device status and alarm information to the user via display devices provided by Ascom or third-party companies. Users receive, time-critical information from connected medical devices directly via their display devices as text, alarms or data. Digistat Smart Central allows users to be aware of their patients’ status and alarm conditions when they are away from the patient and associated medical devices. FDA UDI

Identifiers

Primary DI / UDI-DI: 17350097870032 FDA UDI
510(k) Number: K180430 FDA UDI
FDA Product Code: PHC FDA UDI
MSX FDA UDI
GMDN Term: Alarm application software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5725 FDA UDI
870.2300 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

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Expiration Date

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Manufacturing Date

Yes

FDA UDI

Category: Alarm application software

Digistat Smart Central by Ascom Ums Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Engage Medical Device Alarm Notification System (EMDAN) — Stryker Corp. · Class II
Cerner CareAware Event Management — Cerner Corporation · Class II
Messenger — SPOK INC. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Ascom Ums Srl

Sources (1)

FDA UDI d58b40f0-ad0e-4ddd-9be5-86a73d6ee9da 34 fields · synced May 30, 2026