AccessGUDID - DEVICE: prolaio Personalized Physiology Analytics Engine Software (PPA) (00850071330038)

GUDID

Device Identifier (DI) Information

Brand Name: prolaio Personalized Physiology Analytics Engine Software (PPA)
Version or Model: 1.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Prolaio, Inc.

Primary DI Number: 00850071330038
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118827870 *Terms of Use

Device Description: prolaio Personalized Physiology Analytics Engine Software

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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:	Yes
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?
36365	Electrocardiography monitoring system receiver	An electrically-powered component of an electrocardiograpy telemetric monitoring system designed to wirelessly receive, consolidate, and display electrocardiographic (ECG) signals [sometimes with an additional parameter such as haemoglobin oxygen saturation (SpO2)] from a transmitter connected to a patient, typically ambulatory, for viewing at a receiving location (e.g., central station, bedside monitor).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PLB	Multivariate Vital Signs Index

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142512	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: 6a4e1caa-bc17-4fc2-954b-15cc18ceee56
Public Version Date: June 23, 2025
Public Version Number: 1
DI Record Publish Date: June 13, 2025