AccessGUDID - DEVICE: SpassageQ (08809957910002)

GUDID

Device Identifier (DI) Information

Brand Name: SpassageQ
Version or Model: 1.0.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Spass Co.,Ltd.

Primary DI Number: 08809957910002
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 694978434 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
66625	Physiologic monitor-installed software	An application software program intended to be installed on a dedicated monitoring device (i.e., software in a medical device), to process and display real-time patient physiologic data [e.g., electrocardiogram (ECG), blood pressure, heart rate, SpO2] to facilitate data viewing, management, and communication in a clinical setting. It may in addition notify clinicians of events, patients at risk, and/or manage workflows. It is not intended for intraoperative/intraprocedural monitoring and is neither dedicated to neonatal nor obstetrical monitoring.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PLB	Multivariate Vital Signs Index

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K230386	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 31f70969-4644-4958-9d3c-0154e7f75728
Public Version Date: July 05, 2023
Public Version Number: 1
DI Record Publish Date: June 27, 2023