HOLTER CONNECT

GUDID B353LA1252R1

HOLTER CONNECT Relay Application is a software that is installed on a compatible commercially available platform (mobile or tablet) that manages secured wireless communication between the Biosensor and the HOLTER CONNECT Secure Server for transferring acquired ECG data by the Biosensor.

LIFESIGNALS, INC.

Physiological measuring device wireless data capture/transfer unit
Primary Device IDB353LA1252R1
NIH Device Record Key61eeb35b-e9d7-4dfb-9351-b72269ab3640
Commercial Distribution StatusIn Commercial Distribution
Brand NameHOLTER CONNECT
Version Model NumberLA1252R
Company DUNS798830720
Company NameLIFESIGNALS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone510.770.6412
Emaillssupport@lifesignals.com
Phone510.770.6412
Emaillssupport@lifesignals.com
Phone510.770.6412
Emaillssupport@lifesignals.com
Phone510.770.6412
Emaillssupport@lifesignals.com
Phone510.770.6412
Emaillssupport@lifesignals.com
Phone510.770.6412
Emaillssupport@lifesignals.com
Phone510.770.6412
Emaillssupport@lifesignals.com
Phone510.770.6412
Emaillssupport@lifesignals.com
Phone510.770.6412
Emaillssupport@lifesignals.com
Phone510.770.6412
Emaillssupport@lifesignals.com
Phone510.770.6412
Emaillssupport@lifesignals.com
Phone510.770.6412
Emaillssupport@lifesignals.com
Phone510.770.6412
Emaillssupport@lifesignals.com
Phone510.770.6412
Emaillssupport@lifesignals.com
Phone510.770.6412
Emaillssupport@lifesignals.com
Phone510.770.6412
Emaillssupport@lifesignals.com
Phone510.770.6412
Emaillssupport@lifesignals.com
Phone510.770.6412
Emaillssupport@lifesignals.com
Phone510.770.6412
Emaillssupport@lifesignals.com
Phone510.770.6412
Emaillssupport@lifesignals.com
Phone510.770.6412
Emaillssupport@lifesignals.com
Phone510.770.6412
Emaillssupport@lifesignals.com
Phone510.770.6412
Emaillssupport@lifesignals.com
Phone510.770.6412
Emaillssupport@lifesignals.com
Phone510.770.6412
Emaillssupport@lifesignals.com
Phone510.770.6412
Emaillssupport@lifesignals.com
Phone510.770.6412
Emaillssupport@lifesignals.com
Phone510.770.6412
Emaillssupport@lifesignals.com
Phone510.770.6412
Emaillssupport@lifesignals.com
Phone510.770.6412
Emaillssupport@lifesignals.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB353LA1252R1 [Primary]

FDA Product Code

DRGTransmitters And Receivers, Physiological Signal, Radiofrequency

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-23
Device Publish Date2021-11-15

On-Brand Devices [HOLTER CONNECT]

B353LA1252R1HOLTER CONNECT Relay Application is a software that is installed on a compatible commercially av
B353LA1252C1HOLTER CONNECT business logic is a software running on cloud platform that provides interface fo

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