ER9W 3GSM Brookings

GUDID B146ERW3G020

BRAEMAR MANUFACTURING, LLC

Electrocardiography telemetric monitoring system
Primary Device IDB146ERW3G020
NIH Device Record Key7cd6505a-a394-4477-a020-d636955178f5
Commercial Distribution StatusIn Commercial Distribution
Brand NameER9W 3GSM Brookings
Version Model Number900-0614-02
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
HIBCCB146ERW3G020 [Primary]

FDA Product Code

DRGTransmitters And Receivers, Physiological Signal, Radiofrequency

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-10-21
Device Publish Date2019-10-08

Devices Manufactured by BRAEMAR MANUFACTURING, LLC

B146C6R30 - C6 Sensor 3.0, Rebuilt2024-07-04
B146EP25R0 - ePatch Sensor 2.5, Rebuilt2024-07-04
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

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