Frontier X Plus

GUDID 08908013617128

Single-lead ECG monitor intended to capture, store, transmit and display electrocardiogram (ECG) information for long term monitoring and evaluation.

FOURTH FRONTIER TECHNOLOGIES PRIVATE LIMITED

Electrocardiographic long-term ambulatory recording analyser
Primary Device ID08908013617128
NIH Device Record Key203a214f-0371-4d9c-b9a1-8afd250bf503
Commercial Distribution StatusIn Commercial Distribution
Brand NameFrontier X Plus
Version Model NumberFrontier X Plus
Company DUNS860277087
Company NameFOURTH FRONTIER TECHNOLOGIES PRIVATE LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
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

Phone15128817266
Emailsupport@fourthfrontier.com
Phone15128817266
Emailsupport@fourthfrontier.com
Phone15128817266
Emailsupport@fourthfrontier.com
Phone15128817266
Emailsupport@fourthfrontier.com
Phone15128817266
Emailsupport@fourthfrontier.com
Phone15128817266
Emailsupport@fourthfrontier.com
Phone15128817266
Emailsupport@fourthfrontier.com
Phone15128817266
Emailsupport@fourthfrontier.com
Phone15128817266
Emailsupport@fourthfrontier.com
Phone15128817266
Emailsupport@fourthfrontier.com
Phone15128817266
Emailsupport@fourthfrontier.com
Phone15128817266
Emailsupport@fourthfrontier.com
Phone15128817266
Emailsupport@fourthfrontier.com
Phone15128817266
Emailsupport@fourthfrontier.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108908013617128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MLOElectrocardiograph, Ambulatory, With Analysis Algorithm

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-17
Device Publish Date2025-02-07

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