prolaio Heart Rhythm and Respiration Module

GUDID 00850071330045

prolaio Heart Rhythm and Respiration Module

Prolaio, Inc.

Electrocardiography monitoring system receiver
Primary Device ID00850071330045
NIH Device Record Key1b476ff7-73a6-482c-9027-cb7c32257641
Commercial Distribution StatusIn Commercial Distribution
Brand Nameprolaio Heart Rhythm and Respiration Module
Version Model Number3.0
Company DUNS118827870
Company NameProlaio, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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
GS100850071330045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DPSElectrocardiograph

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 Cloud2025-06-23 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 Module2025-06-23prolaio Heart Rhythm and Respiration Module
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

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