prolaio Cloud

GUDID 00850071330014

prolaio medical device data system cloud

Prolaio, Inc.

Electrocardiography monitoring system receiver
Primary Device ID00850071330014
NIH Device Record Key4d123c1e-a894-4ac4-bdcf-0b0a04de6190
Commercial Distribution StatusIn Commercial Distribution
Brand Nameprolaio Cloud
Version Model NumberDP-21-03
Company DUNS118827870
Company NameProlaio, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855-869-9054
Emailsupport@prolaio.com
Phone855-869-9054
Emailsupport@prolaio.com
Phone855-869-9054
Emailsupport@prolaio.com
Phone855-869-9054
Emailsupport@prolaio.com
Phone855-869-9054
Emailsupport@prolaio.com
Phone855-869-9054
Emailsupport@prolaio.com
Phone855-869-9054
Emailsupport@prolaio.com
Phone855-869-9054
Emailsupport@prolaio.com
Phone855-869-9054
Emailsupport@prolaio.com
Phone855-869-9054
Emailsupport@prolaio.com
Phone855-869-9054
Emailsupport@prolaio.com
Phone855-869-9054
Emailsupport@prolaio.com
Phone855-869-9054
Emailsupport@prolaio.com
Phone855-869-9054
Emailsupport@prolaio.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850071330014 [Primary]

FDA Product Code

OUGMedical Device Data System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-23
Device Publish Date2025-06-13

Devices Manufactured by Prolaio, Inc.

00850071330007 - prolaio Mobile App2025-06-23 prolaio medical device data system mobile application
00850071330014 - prolaio Cloud2025-06-23prolaio medical device data system cloud
00850071330014 - prolaio Cloud2025-06-23 prolaio medical device data system cloud
00850071330038 - prolaio Personalized Physiology Analytics Engine Software (PPA)2025-06-23 prolaio Personalized Physiology Analytics Engine Software
00850071330045 - prolaio Heart Rhythm and Respiration Module2025-06-23 prolaio Heart Rhythm and Respiration Module
00850071330069 - prolaio Convenience Kit2025-06-23 prolaio Convenience Kit - Model D
00850071330076 - prolaio Convenience Kit2025-06-23 prolaio Convenience Kit - Model C
00850071330083 - prolaio Convenience Kit2025-06-23 prolaio Convenience Kit - Model F
00850071330090 - prolaio Convenience Kit2025-06-23 prolaio Convenience Kit - Model B

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.