PER900 Braemar

GUDID B146PERB0

ENHANCED ALGORITHM ECG EVENT RECORDER

BRAEMAR MANUFACTURING, LLC

Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system
Primary Device IDB146PERB0
NIH Device Record Key2c9ea7e0-7764-4af8-a9ab-c52c736e274e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePER900 Braemar
Version Model Number900-0553-03
Company DUNS049529118
Company NameBRAEMAR MANUFACTURING, LLC
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB146PERB0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MWJElectrocardiograph,Ambulatory(Without Analysis)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-11

Devices Manufactured by BRAEMAR MANUFACTURING, LLC

B146C6M20 - C6 Monitor UGW2023-12-14
B146EP2510 - ePatch 2.5, BTH2023-12-13
B146EP2520 - ePatch 2.5, BTI2023-11-30
B146C6M60 - C6 Monitor A10e, Sprint2023-06-23
B146C6M80 - C6 Monitor A13, T Mobile2023-06-23
B146C6M90 - C6 Monitor A13, Verizon2023-06-23
B146EP2R10 - ePatch 2.0 rebuilt2022-07-21
B146EPE1 - ePatch Electrode-patch2022-04-08

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