SpassageQ

GUDID 08809957910002

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.

Spass Co.,Ltd.

Physiologic monitor-installed software

• Primary Device ID: 08809957910002
• NIH Device Record Key: 31f70969-4644-4958-9d3c-0154e7f75728
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpassageQ
• Version Model Number: 1.0.0
• Company DUNS: 694978434
• Company Name: Spass Co.,Ltd.
• 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: true
• 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	08809957910002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230386

FDA Product Code

• PLB: Multivariate Vital Signs Index

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: 2023-07-05
• Device Publish Date: 2023-06-27