SpassageQ

FDA UDI

Class II (US FDA UDI)

by Spass, Inc.

Identity

Trade Name: SpassageQ FDA UDI
Generic Name: Physiologic monitor-installed software FDA UDI
Device Name: The SpassageQ is a SaMD that automatically calculates the patient’s qSOFA score based on the six vital signs received from the HL7 gateway system and the GCS directly entered by the healthcare provider and notifies the user of signs of sepsis through visual alarms. FDA UDI
Model / Reference: 1.0.0 FDA UDI
Description: The SpassageQ is a SaMD that automatically calculates the patient’s qSOFA score based on the six vital signs received from the HL7 gateway system and the GCS directly entered by the healthcare provider and notifies the user of signs of sepsis through visual alarms. FDA UDI

Identifiers

Primary DI / UDI-DI: 08809957910002 FDA UDI
510(k) Number: K230386 FDA UDI
FDA Product Code: PLB FDA UDI
GMDN Term: Physiologic monitor-installed software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Physiologic monitor-installed software

SpassageQ by Spass, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Physiologic monitor-installed software.

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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: Spass, Inc.

Sources (1)

FDA UDI 31f70969-4644-4958-9d3c-0154e7f75728 34 fields · synced May 31, 2026